An observational study in Exocrine Pancreatic Insufficiency, Pancreatic Diseases and Digestive System Diseases, sponsored by Mylan Inc.. Completed at 189 sites in Japan. Open to participants aged 1 Year to 99 Years. Per ClinicalTrials.gov, last updated 2022-06-13.
Sponsored by Mylan Inc. · Observational
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.
Criteria for evaluation:
Nutritional endpoints
Symptoms related to exocrine pancreatic insufficiency
613 studies on the registry are indexed under Digestive System Diseases; 117 are open to participants now.
This study's enrollment of 579 is above the median of 272 across 193 observational studies indexed under Digestive System Diseases.
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Counted across the registry records on this site, refreshed daily.
Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
Exclusion Criteria
In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day. Also, the dose was adjusted appropriately according to the patient's condition.
Drug: Lipacreon
This study was an observational study and no intervention was specified
Number of Patients With Adverse Drug Reaction
An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR). 1. Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved. 2. Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE
Time frame: At week 52
Degree of General Improvement
It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable
Time frame: At week 24
Degree of General Improvement
It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable
Time frame: At week 52
Nutritional Endpoints - BMI
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutritional Endpoints - Serum Total Protein
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Albumin
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Total Cholesterol
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Physical Health (Summary)
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. PCS8 score is calculated by the following formula (All summed). PCS8 score = (0.23024×SF8GH)+(0.40672×SF8PF)+(0.38317×SF8RP)+(0.33295×SF8BP)+(0.07537×SF8VT)+(-0.01275×SF8SF)+(-0.30469×SF8MH)+(-0.14803×SF8RE)+0.67371 The minimum value of PCS8 is 5.315, and the maximum value is 70.689. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Triglycerides
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Haemoglobin
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Mental Health (Summary)
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. MCS8 score is calculated by the following formula (All summed). MCS8 score = (-0.02020×SF8GH)+(-0.19972×SF8PF)+(-0.16579×SF8RP)+(-0.15992×SF8BP)+(0.16737×SF8VT)+(0.27264×SF8SF)+(0.57583×SF8MH)+(0.42927×SF8RE)+4.34744 The minimum value of MCS8 is 10.108, and the maximum value is 74.511. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - General Health
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8GH scores; 1:63.38, 2:58.54, 3:50.27, 4:40.40, 5:34.38, 6:26.89 The minimum value of SF8GH is 26.89, and the maximum value is 63.38. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Physical Functioning
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8PF scores; 1:53.54, 2:47.77, 3:41.45, 4:27.59, 5:16.69 The minimum value of SF8PF is 16.69, and the maximum value is 53.54. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Role Physical
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8RP scores; 1:54.09, 2:47.42, 3:40.65, 4:27.91, 5:21.80. The minimum value of SF8RP is 21.80, and the maximum value is 54.09. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Body Pain
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8BP scores; 1:60.35, 2:52.46, 3:46.10, 4:38.21, 5:31.59, 6:21.68. The minimum value of SF8BP is 21.68, and the maximum value is 60.35. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Vitality
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8VT scores; 1:60.01, 2:53.74, 3:44.48, 4:38.51, 5:28.68. The minimum value of SF8VT is 28.68, and the maximum value is 60.01. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Social Functioning
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8SF scores; 1:55.14, 2:45.60, 3:37.65, 4:29.15, 5:26.00. The minimum value of SF8SF is 26.00, and the maximum value is 55.14. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Mental Health
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8MH scores; 1:56.93, 2:50.72, 3:44.94, 4:36.30, 5:27.59. The minimum value of SF8MH is 27.59, and the maximum value is 56.93. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Role Emotional
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8RE scores; 1:54.19, 2:48.04, 3:42.24, 4:31.42, 5:19.98. The minimum value of SF8RE is 19.98, and the maximum value is 54.19. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
From August 30, 2011 to July 31, 2014, 579 patients were registered at 144 departments of 136 facilities (patient registration period: August 30, 2011 to July 31, 2014) and the survey forms of 562 patients were collected from 140 departments of 132 facilities.
| Milestone | LipaCreon |
|---|---|
| Started | 579 |
| Collected crfs | 562 |
| Safety analysis set | 553 |
| Completed | 378 |
| Not completed | 201 |
| Withdrew: Lost to follow-up | 17 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Drug not administered | 1 |
| Withdrew: Failure to visit | 7 |
| Withdrew: Adverse event | 46 |
| Withdrew: Failure to visit after administration | 40 |
| Withdrew: Patient's rejection | 27 |
| Withdrew: Transfer to a different hospital | 17 |
| Withdrew: Lack of efficacy | 8 |
| Withdrew: Death | 7 |
| Withdrew: Symptom improvement | 6 |
| Withdrew: Ae and patient's rejection | 5 |
| Withdrew: Physician decision | 5 |
| Withdrew: Exacerbation of underlying disease | 5 |
| Withdrew: Oral feeding difficulty | 5 |
| Withdrew: Lack of efficacy and patient's rejection | 1 |
| Withdrew: Forgetting prescription | 1 |
| Withdrew: Other | 2 |
An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR). 1. Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved. 2. Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE
| participants | LipaCreon |
|---|---|
| Number of Patients With Adverse Drug Reaction | 36 |
It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable
| Participants | Lipacreon |
|---|---|
| Improved | 299 |
| Unchanged | 87 |
| Exacerbated | 3 |
| Unassessable | 15 |
It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable
| Participants | Lipacreon |
|---|---|
| Improved | 240 |
| Unchanged | 62 |
| Exacerbated | 1 |
| Unassessable | 11 |
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
| kg/m2 | Lipacreon |
|---|---|
| Baseline | 20.452 ± 3.144 |
| 4 weeks | 20.193 ± 2.933 |
| 8 weeks | 20.229 ± 2.991 |
| 24 weeks | 20.520 ± 2.847 |
| 52 weeks | 20.720 ± 2.853 |
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
| g/dL | Lipacreon |
|---|---|
| Baseline | 6.579 ± 0.798 |
| 4 weeks | 6.955 ± 3.500 |
| 8 weeks | 6.761 ± 0.654 |
| 24 weeks | 6.901 ± 0.596 |
| 52 weeks | 6.914 ± 0.637 |
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
| g/dL | Lipacreon |
|---|---|
| Baseline | 3.688 ± 0.663 |
| 4 weeks | 3.912 ± 2.164 |
| 8 weeks | 3.843 ± 0.628 |
| 24 weeks | 3.984 ± 0.509 |
| 52 weeks | 3.959 ± 0.579 |
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
| mg/dL | Lipacreon |
|---|---|
| Baseline | 164.32 ± 47.63 |
| 4 weeks | 169.40 ± 45.34 |
| 8 weeks | 169.77 ± 45.99 |
| 24 weeks | 168.88 ± 39.90 |
| 52 weeks | 169.41 ± 38.27 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. PCS8 score is calculated by the following formula (All summed). PCS8 score = (0.23024×SF8GH)+(0.40672×SF8PF)+(0.38317×SF8RP)+(0.33295×SF8BP)+(0.07537×SF8VT)+(-0.01275×SF8SF)+(-0.30469×SF8MH)+(-0.14803×SF8RE)+0.67371 The minimum value of PCS8 is 5.315, and the maximum value is 70.689. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 42.057 ± 9.590 |
| 8 weeks | 46.086 ± 7.750 |
| 24 weeks | 47.919 ± 7.414 |
| 52 weeks | 48.985 ± 7.109 |
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
| participants | Lipacreon |
|---|---|
| Baseline, Yes | 84 |
| Baseline, No | 386 |
| 4 weeks, Yes | 33 |
| 4 weeks, No | 330 |
| 8 weeks, Yes | 22 |
| 8 weeks, No | 333 |
| 24 weeks, Yes | 15 |
| 24 weeks, No | 332 |
| 52 weeks, Yes | 6 |
| 52 weeks, No | 270 |
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
| mg/dL | Lipacreon |
|---|---|
| Baseline | 123.5 ± 115.0 |
| 4 weeks | 128.8 ± 95.4 |
| 8 weeks | 118.6 ± 90.1 |
| 24 weeks | 117.9 ± 70.6 |
| 52 weeks | 126.5 ± 103.5 |
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total cholesterol * Triglycerides * Haemoglobin
| g/dL | Lipacreon |
|---|---|
| Baseline | 12.18 ± 1.99 |
| 4 weeks | 12.03 ± 1.84 |
| 8 weeks | 12.12 ± 1.95 |
| 24 weeks | 12.40 ± 1.96 |
| 52 weeks | 12.58 ± 1.88 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. MCS8 score is calculated by the following formula (All summed). MCS8 score = (-0.02020×SF8GH)+(-0.19972×SF8PF)+(-0.16579×SF8RP)+(-0.15992×SF8BP)+(0.16737×SF8VT)+(0.27264×SF8SF)+(0.57583×SF8MH)+(0.42927×SF8RE)+4.34744 The minimum value of MCS8 is 10.108, and the maximum value is 74.511. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 44.619 ± 8.405 |
| 8 weeks | 47.864 ± 7.255 |
| 24 weeks | 49.288 ± 6.230 |
| 52 weeks | 49.894 ± 6.308 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8GH scores; 1:63.38, 2:58.54, 3:50.27, 4:40.40, 5:34.38, 6:26.89 The minimum value of SF8GH is 26.89, and the maximum value is 63.38. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 43.673 ± 8.513 |
| 8 weeks | 48.238 ± 7.395 |
| 24 weeks | 50.250 ± 7.306 |
| 52 weeks | 51.479 ± 7.030 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8PF scores; 1:53.54, 2:47.77, 3:41.45, 4:27.59, 5:16.69 The minimum value of SF8PF is 16.69, and the maximum value is 53.54. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 41.941 ± 10.463 |
| 8 weeks | 45.630 ± 8.628 |
| 24 weeks | 47.438 ± 7.617 |
| 52 weeks | 48.325 ± 7.166 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8RP scores; 1:54.09, 2:47.42, 3:40.65, 4:27.91, 5:21.80. The minimum value of SF8RP is 21.80, and the maximum value is 54.09. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 41.325 ± 10.707 |
| 8 weeks | 45.253 ± 8.983 |
| 24 weeks | 47.371 ± 8.034 |
| 52 weeks | 48.222 ± 7.553 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8BP scores; 1:60.35, 2:52.46, 3:46.10, 4:38.21, 5:31.59, 6:21.68. The minimum value of SF8BP is 21.68, and the maximum value is 60.35. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 48.282 ± 10.178 |
| 8 weeks | 52.407 ± 8.162 |
| 24 weeks | 53.746 ± 7.906 |
| 52 weeks | 54.594 ± 7.852 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8VT scores; 1:60.01, 2:53.74, 3:44.48, 4:38.51, 5:28.68. The minimum value of SF8VT is 28.68, and the maximum value is 60.01. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 44.425 ± 8.216 |
| 8 weeks | 48.408 ± 7.718 |
| 24 weeks | 50.263 ± 7.183 |
| 52 weeks | 51.463 ± 6.919 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8SF scores; 1:55.14, 2:45.60, 3:37.65, 4:29.15, 5:26.00. The minimum value of SF8SF is 26.00, and the maximum value is 55.14. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 42.345 ± 10.332 |
| 8 weeks | 46.073 ± 9.255 |
| 24 weeks | 47.749 ± 8.393 |
| 52 weeks | 48.633 ± 7.973 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8MH scores; 1:56.93, 2:50.72, 3:44.94, 4:36.30, 5:27.59. The minimum value of SF8MH is 27.59, and the maximum value is 56.93. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 46.066 ± 8.459 |
| 8 weeks | 49.619 ± 7.245 |
| 24 weeks | 51.326 ± 6.267 |
| 52 weeks | 51.745 ± 6.395 |
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows. Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE. SF8RE scores; 1:54.19, 2:48.04, 3:42.24, 4:31.42, 5:19.98. The minimum value of SF8RE is 19.98, and the maximum value is 54.19. Higher scores mean a better outcome. The means ± SD was calculated by summing the values at each time point.
| score on a scale | Lipacreon |
|---|---|
| Baseline | 43.320 ± 9.704 |
| 8 weeks | 47.179 ± 7.930 |
| 24 weeks | 48.670 ± 6.778 |
| 52 weeks | 49.607 ± 6.561 |
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
| times/day | Lipacreon |
|---|---|
| Baseline | 2.37 ± 1.87 |
| 4 weeks | 1.82 ± 1.33 |
| 8 weeks | 1.77 ± 1.42 |
| 24 weeks | 1.51 ± 0.96 |
| 52 weeks | 1.43 ± 0.81 |
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
| participants | Lipacreon |
|---|---|
| Baseline, Yes | 187 |
| Baseline, No | 296 |
| 4 weeks, Yes | 81 |
| 4 weeks, No | 295 |
| 8 weeks, Yes | 72 |
| 8 weeks, No | 293 |
| 24 weeks, Yes | 45 |
| 24 weeks, No | 313 |
| 52 weeks, Yes | 29 |
| 52 weeks, No | 256 |
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
| participants | Lipacreon |
|---|---|
| Baseline, Yes | 83 |
| Baseline, No | 377 |
| 4 weeks, Yes | 37 |
| 4 weeks, No | 323 |
| 8 weeks, Yes | 30 |
| 8 weeks, No | 320 |
| 24 weeks, Yes | 21 |
| 24 weeks, No | 323 |
| 52 weeks, Yes | 18 |
| 52 weeks, No | 256 |
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
| participants | Lipacreon |
|---|---|
| Baseline, Yes | 169 |
| Baseline, No | 313 |
| 4 weeks, Yes | 72 |
| 4 weeks, No | 304 |
| 8 weeks, Yes | 58 |
| 8 weeks, No | 304 |
| 24 weeks, Yes | 37 |
| 24 weeks, No | 318 |
| 52 weeks, Yes | 17 |
| 52 weeks, No | 266 |
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period. * Steatorrhoea (Yes/No) * Frequency of bowel movements (times/day) * Diarrhoea (Yes/No) * Foul stool odour (Yes/No) * Decreased appetite (Yes/No) * Abdominal distension (Yes/No)
| participants | Lipacreon |
|---|---|
| Baseline, Yes | 130 |
| Baseline, No | 345 |
| 4 weeks, Yes | 42 |
| 4 weeks, No | 330 |
| 8 weeks, Yes | 37 |
| 8 weeks, No | 322 |
| 24 weeks, Yes | 27 |
| 24 weeks, No | 324 |
| 52 weeks, Yes | 12 |
| 52 weeks, No | 268 |
Collected over From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 52 weeks in the study completers (From date of dosage start, up to 52 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LipaCreon | 0/553 (0%) | 81/553 (14.6%) | 0/553 (0%) |
| Event | LipaCreon |
|---|---|
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 17/553 |
| Decreased appetiteMetabolism and nutrition disorders | 6/553 |
| Pancreatic carcinoma recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/553 |
| Malignant ascitesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/553 |
| Cancer painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/553 |
| Bile duct cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/553 |
| Gastric ulcerGastrointestinal disorders | 3/553 |
| CholangitisHepatobiliary disorders | 3/553 |
| Jaundice cholestaticHepatobiliary disorders | 3/553 |
| Protein total decreasedInvestigations | 3/553 |
553 are effctive number for safety analysis
| Age, Categorical(Participants) | LipaCreon |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 243 |
| >=65 years | 310 |
| Age, Continuous(years) | LipaCreon |
|---|---|
| Mean | 65.2 ± 12.7 |
| Sex: Female, Male(Participants) | LipaCreon |
|---|---|
| Female | 210 |
| Male | 343 |
| Region of Enrollment(participants) | LipaCreon |
|---|---|
| Japan | 553 |
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