N/A
N=1,194
Drug Use Investigation Of Gabapentin
Epilepsies, Partial
Bottom Line
View on ClinicalTrials.gov: NCT00567268 ↗Enrolled (actual)
1,194
Serious AEs
2.5%
Results posted
May 2015
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert — 27 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gabapentin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert |
27 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
231 | — |
| PRIMARY Clinical Efficacy Rate |
61.1 | — |
| SECONDARY Response Ratio (R Ratio) |
-0.410 | — |
| SECONDARY Responder Rate |
55.0 | — |
| SECONDARY Percent Reduction From Baseline in Epileptic Seizure Frequency |
-34.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
Patients need to be taking Gabapentin in order to be enrolled in the surveillance
Exclusion Criteria
Patients not taking Gabapentin
Data sourced from ClinicalTrials.gov (NCT00567268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.