N/A
N=197
Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
Post Herpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT01426230 ↗Enrolled (actual)
197
Serious AEs
2.5%
Results posted
Mar 2013
Primary outcome: Primary: Change From Baseline to End of Study in LOCF VAS — -20.4; -21.3 scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Depomed
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Study in LOCF VAS |
-20.4; -21.3 | — |
Summary
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
Eligibility Criteria
Inclusion Criteria
- Men or Women 18 years or older who are suffering from PHN
Exclusion Criteria
- Patient is Pregnant or a nursing mother
- Patient has hypersensitivity to gabapentin
- Patient has an estimated creatinine clearance of <30 mL/min or is in hemodialysis
Data sourced from ClinicalTrials.gov (NCT01426230). 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.