A Phase 3 interventional study of pregabalin in Diabetic Neuropathy, Painful, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 27 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 123 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
Summary of Adverse Events
Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.
Time frame: 53 weeks
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.
Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
Thirty-six (36) centers in Japan
| Milestone | Pregabalin |
|---|---|
| Started | 123 |
| Completed | 97 |
| Not completed | 26 |
| Withdrew: Adverse event | 19 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Physician decision | 1 |
Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.
| participants | Pregabalin |
|---|---|
| Participants with adverse events | 114 |
| Participants with serious adverse events | 21 |
| Participants with severe adverse events | 7 |
| Participants discontinued due to adverse events | 17 |
| Dose reduced or temporary discontinuation | 43 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.
| score on scale | Pregabalin |
|---|---|
| Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | -3.5 ± 5.1 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.
| score on scale | Pregabalin |
|---|---|
| Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | -1.2 ± 2.4 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.
| score on scale | Pregabalin |
|---|---|
| Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | -4.7 ± 6.8 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.
| mm | Pregabalin |
|---|---|
| Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | -25.4 ± 26.4 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.
| score on scale | Pregabalin |
|---|---|
| Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | -0.7 ± 1.1 |
Collected over 53 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | — | 21/123 (17.1%) | 101/123 (82.1%) |
| Event | Pregabalin |
|---|---|
| PneumoniaInfections and infestations | 3/123 |
| CellulitisInfections and infestations | 2/123 |
| Cerebral infarctionNervous system disorders | 2/123 |
| Atrioventricular block completeCardiac disorders | 1/123 |
| Meniere's diseaseEar and labyrinth disorders | 1/123 |
| Diabetic gangreneInfections and infestations | 1/123 |
| Femoral neck fractureInjury, poisoning and procedural complications | 1/123 |
| Femur fractureInjury, poisoning and procedural complications | 1/123 |
| Hand fractureInjury, poisoning and procedural complications | 1/123 |
| Thermal burnInjury, poisoning and procedural complications | 1/123 |
| Event | Pregabalin |
|---|---|
| NasopharyngitisInfections and infestations | 39/123 |
| Weight increasedInvestigations | 35/123 |
| SomnolenceNervous system disorders | 30/123 |
| DizzinessNervous system disorders | 29/123 |
| Oedema peripheralGeneral disorders | 21/123 |
| FallInjury, poisoning and procedural complications | 14/123 |
| ConstipationGastrointestinal disorders | 11/123 |
| Face oedemaGeneral disorders | 10/123 |
| EczemaSkin and subcutaneous tissue disorders | 10/123 |
| Diabetic retinopathyEye disorders | 9/123 |
| Age, Customized(participants) | Pregabalin |
|---|---|
| < 18 years | 0 |
| 18 - 44 years | 6 |
| 45 - 64 years | 71 |
| >= 65 years | 46 |
| Age, Customized(years) | Pregabalin |
|---|---|
| Mean | 61.7 ± 10.0 |
| Sex: Female, Male(Participants) | Pregabalin |
|---|---|
| Female | 23 |
| Male | 100 |
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.