An observational study in Epilepsies, Partial, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Observational
The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes the first Gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
254 studies on the registry are indexed under Epilepsies, Partial; 48 are open to participants now.
This study's enrollment of 1,273 is above the median of 101 across 48 observational studies indexed under Epilepsies, Partial.
Browse Epilepsies, Partial 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.
The patients whom an investigator involving A9451163 prescribes the Gabapentin
Patients need to be taking Gabapentin in order to be enrolled in the surveillance
Exclusion Criteria:
Patients not taking Gabapentin
Patients taking Gabapentin
Drug: Gabapentin
GABAPEN Tablets 200mg, GABAPEN Tablets 300mg, GABAPEN Tablets 400mg. GABAPEN is Brand name in Japan. Dosage, frequency: According to Japanese LPD, "Normally, oral gabapentin 600 mg, 3 div., should be given on the first day of administration and an effective dose of 1200mg, 3 div, should be given on day 2. From day 3 on, adults should be maintained on oral gabapentin 1200 mg to 1800 mg, 3 div. Subsequently, the maintenance dose should be suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg)". Duration: According to the protocol of A9451163, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 12 weeks after the first administration.
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).
Time frame: 12 weeks
Number of Participants With Treatment-Related Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).
Time frame: 12 weeks
Clinical Efficacy Rate
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.
Time frame: 12 weeks
Response Ratio (R Ratio)
Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure.
Time frame: 12 weeks
Responder Rate
Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.
Time frame: 12 weeks
Percent Reduction From Baseline in Epileptic Seizure Frequency
Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = \[(T-B)/B\] X 100.
Time frame: 12 weeks
Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events.
Time frame: 12 weeks
Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events.
Time frame: 12 weeks
Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years)
Participants who responded to the treatment with gabapentin were counted by age (\<65 vs. \>=65 years) to assess whether the age was a factor affecting the treatment efficacy.
Time frame: 12 weeks
Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories
Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy.
Time frame: 12 weeks
Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure
Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy.
Time frame: 12 weeks
Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure
Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (\<=8 vs. \>8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.
Time frame: 12 weeks
Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline
Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.
Time frame: 12 weeks
Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance
Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy.
Time frame: 12 weeks
Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy
Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy.
Time frame: 12 weeks
| Milestone | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Started | 1194 |
| Completed | 1144 |
| Not completed | 50 |
| Withdrew: Protocol violation | 7 |
| Withdrew: Lost to follow-up | 36 |
| Withdrew: No visit after first day of treatment | 2 |
| Withdrew: No drug administration | 4 |
| Withdrew: Safety evaluation "not assessable" | 1 |
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).
| participants | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 27 |
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).
| participants | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Number of Participants With Treatment-Related Adverse Events | 231 |
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.
| Percentage of participants | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Clinical Efficacy Rate | 61.1 (58.1 to 64.1) |
Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure.
| Ratio | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Response Ratio (R Ratio) | -0.410 ± 0.4855 |
Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.
| Percentage of participants | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Responder Rate | 55.0 (51.8 to 58.2) |
Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = \[(T-B)/B\] X 100.
| Percentage | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Percent Reduction From Baseline in Epileptic Seizure Frequency | -34.0 ± 103.70 |
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events.
| participants | Age <15 Years | Age >=15 and <25 Years | Age >=25 and <35 Years | Age >=35 and <45 Years | Age >=45 and <55 Years | Age >=55 and <65 Years | Age >=65 Years |
|---|---|---|---|---|---|---|---|
| Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 27 | 31 | 52 | 58 | 15 | 26 | 22 |
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events.
| participants | No Concomitant Antiepileptic Drug | One Concomitant Antiepileptic Drug | Two Concomitant Antiepileptic Drugs | Three Concomitant Antiepileptic Drugs | Four or More Concomitant Antiepileptic Drugs |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 12 | 70 | 91 | 41 | 17 |
Participants who responded to the treatment with gabapentin were counted by age (\<65 vs. \>=65 years) to assess whether the age was a factor affecting the treatment efficacy.
| participants | Age <65 Years | Age >=65 Years |
|---|---|---|
| Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | 545 | 94 |
Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy.
| participants | Age <15 Years | Age >=15 and <25 Years | Age >=25 and <35 Years | Age >=35 and <45 Years | Age >=45 and <55 Years | Age >=55 and <65 Years | Age >=65 Years |
|---|---|---|---|---|---|---|---|
| Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 93 | 91 | 102 | 113 | 64 | 82 | 94 |
Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy.
| participants | Mild | Moderate | Severe |
|---|---|---|---|
| Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure | 150 | 363 | 118 |
Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (\<=8 vs. \>8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.
| participants | <=8 Episodes | >8 Episodes | Unknown |
|---|---|---|---|
| Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure | 432 | 166 | 41 |
Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.
| participants | No Concomitant Antiepileptic Drug | One Concomitant Antiepileptic Drug | Two Concomitant Antiepileptic Drugs | Three Concomitant Antiepileptic Drugs | Four or More Concomitant Antiepileptic Drugs |
|---|---|---|---|---|---|
| Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | 32 | 295 | 190 | 98 | 24 |
Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy.
| participants | CLcr >=60 mL/Min | CLcr >=30 and <60 mL/Min | CLcr >=15 and <30 mL/Min | CLcr >=5 and <15 mL/Min | CLcr <5 mL/Min | Unkown |
|---|---|---|---|---|---|---|
| Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | 284 | 28 | 4 | 1 | — | 322 |
Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy.
| participants | Presence of Non-Drug Therapy | Absence of Non-Drug Therapy |
|---|---|---|
| Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy | 34 | 605 |
Collected over 12 weeks. Non-serious events are listed at a 0.50% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin 200, 300, 400 mg Tablets | — | 29/1,144 (2.5%) | 248/1,144 (21.7%) |
| Event | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Brain neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/1144 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 4/1144 |
| AnaemiaBlood and lymphatic system disorders | 2/1144 |
| SepsisInfections and infestations | 2/1144 |
| PneumoniaInfections and infestations | 2/1144 |
| ConvulsionNervous system disorders | 2/1144 |
| PancytopeniaBlood and lymphatic system disorders | 1/1144 |
| NeoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1144 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1144 |
| Nasal sinus cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1144 |
| Event | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| SomnolenceNervous system disorders | 137/1144 |
| DizzinessNervous system disorders | 40/1144 |
| ConvulsionNervous system disorders | 13/1144 |
| Gamma-glutamyltransferase increasedInvestigations | 11/1144 |
| Decreased activityPsychiatric disorders | 8/1144 |
| MalaiseGeneral disorders | 8/1144 |
| White blood cell count decreasedInvestigations | 7/1144 |
| AtaxiaNervous system disorders | 6/1144 |
| HeadacheNervous system disorders | 6/1144 |
| Hepatic function abnormalHepatobiliary disorders | 6/1144 |
In total, 1194 participants were enrolled in the study. Of the 1194 participants, a total of 50 participants were excluded from the baseline analysis for the following reasons: protocol violation, lost to follow-up, no visit after first day of treatment, no drug administration, and safety evaluation "Not Assessable".
| Age, Customized(participants) | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| <65 years | 1001 |
| >=65 years | 143 |
| Sex: Female, Male(Participants) | Gabapentin 200, 300, 400 mg Tablets |
|---|---|
| Female | 542 |
| Male | 602 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.