Trial · NCT00567268
Drug Use Investigation Of Gabapentin
NCT00567268, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2015-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Drug Use Investigation Of Gabapentin. Trials, record NCT00567268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00567268
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Use Investigation Of Gabapentin
- NCT number
- NCT00567268
- Status
- Completed
- Enrollment
- 1,273 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsies, Partial
- Interventions
- Gabapentin
- First posted
- 2007-12-04
- Last updated
- 2021-02-03
- Results first posted
- 2015-05-12
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 12 weeks | 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.). |
| Primary | Number of Participants With Treatment-Related Adverse Events | 12 weeks | 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.). |
| Primary | Clinical Efficacy Rate | 12 weeks | 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. |
| Secondary | Response Ratio (R Ratio) | 12 weeks | 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. |
| Secondary | Responder Rate | 12 weeks | 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. |
| Secondary | Percent Reduction From Baseline in Epileptic Seizure Frequency | 12 weeks | 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. |
| Other | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 12 weeks | 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. |
| Other | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 12 weeks | 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. |
| Other | Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | 12 weeks | 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. |
| Other | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 12 weeks | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 12 weeks | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-Related Adverse Events | 12 weeks | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | participants | NUMBER |
| PRIMARY | Clinical Efficacy Rate | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency within the safety analysis population. Participants who had disease not eligible for the survey were excluded from the efficacy analysis population. | Percentage of participants | NUMBER |
| SECONDARY | Response Ratio (R Ratio) | 12 weeks | R ratio analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population. | Ratio | MEAN |
| SECONDARY | Responder Rate | 12 weeks | Responder rate analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population. | Percentage of participants | NUMBER |
| SECONDARY | Percent Reduction From Baseline in Epileptic Seizure Frequency | 12 weeks | The analysis population comprised of the participants whose frequency of epileptic seizures during 4 weeks before gabapentin treatment (represented by B) was at least once within the R ratio analysis population. | Percentage | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 12 weeks | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 12 weeks | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | Gabapentin 200, 300, 400 mg Tablets | 27 | participants | ||
| Number of Participants With Treatment-Related Adverse Events | Gabapentin 200, 300, 400 mg Tablets | 231 | participants | ||
| Clinical Efficacy Rate | Gabapentin 200, 300, 400 mg Tablets | 61.1 | 95% Confidence Interval 58.1 to 64.1 | Percentage of participants | |
| Response Ratio (R Ratio) | Gabapentin 200, 300, 400 mg Tablets | -0.410 | Standard Deviation 0.4855 | Ratio | |
| Responder Rate | Gabapentin 200, 300, 400 mg Tablets | 55.0 | 95% Confidence Interval 51.8 to 58.2 | Percentage of participants | |
| Percent Reduction From Baseline in Epileptic Seizure Frequency | Gabapentin 200, 300, 400 mg Tablets | -34.0 | Standard Deviation 103.70 | Percentage | |
| Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | Age <15 Years | 27 | participants | ||
| Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | Age >=15 and <25 Years | 31 | participants | ||
| Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | Age >=25 and <35 Years | 52 | participants | ||
| Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | Age >=35 and <45 Years | 58 | participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin 200, 300, 400 mg Tablets | 1,194 | |
| Overall Study | COMPLETED | Gabapentin 200, 300, 400 mg Tablets | 1,144 | |
| Overall Study | NOT COMPLETED | Gabapentin 200, 300, 400 mg Tablets | 50 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased activity | Psychiatric disorders | Gabapentin 200, 300, 400 mg Tablets | 8 | 1,144 | 8 |
| other | Ataxia | Nervous system disorders | Gabapentin 200, 300, 400 mg Tablets | 6 | 1,144 | 6 |
| other | Somnolence | Nervous system disorders | Gabapentin 200, 300, 400 mg Tablets | 137 | 1,144 | 137 |
| other | Headache | Nervous system disorders | Gabapentin 200, 300, 400 mg Tablets | 6 | 1,144 | 6 |
| other | Dizziness | Nervous system disorders | Gabapentin 200, 300, 400 mg Tablets | 40 | 1,144 | 40 |
| other | Hepatic function abnormal | Hepatobiliary disorders | Gabapentin 200, 300, 400 mg Tablets | 6 | 1,144 | 6 |
| other | Malaise | General disorders | Gabapentin 200, 300, 400 mg Tablets | 8 | 1,144 | 8 |
| other | Gamma-glutamyltransferase increased | Investigations | Gabapentin 200, 300, 400 mg Tablets | 11 | 1,144 | 11 |
| other | White blood cell count decreased | Investigations | Gabapentin 200, 300, 400 mg Tablets | 7 | 1,144 | 7 |
| other | Nausea | Gastrointestinal disorders | Gabapentin 200, 300, 400 mg Tablets | 6 | 1,144 | 6 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin 200, 300, 400 mg Tablets | ||
| Total, other adverse events | Gabapentin 200, 300, 400 mg Tablets | 248 | 1,144 |
| Total, serious adverse events | Gabapentin 200, 300, 400 mg Tablets | 29 | 1,144 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Presence of Non-Drug Therapy vs Absence of Non-Drug Therapy: Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy | Trial comparisons |
| Age <65 Years vs Age >=65 Years: Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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