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NCT00617461 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment
A Phase 2 study of Neuralgia, Postherpetic, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT00617461: Completed Phase 2 study of Neuralgia, Postherpetic, sponsored by XenoPort.
NCT00617461 is a Phase 2 study of Neuralgia, Postherpetic that has completed, run by XenoPort. The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00617461, a Phase 2 study of Neuralgia, Postherpetic, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.
Primary Outcome
Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants rated their API over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as end
Conditions Studied
Interventions
- DRUG GEn 1200mg/day
- DRUG GEn 3600mg/day
Study Locations (20)
Florida
- GSK Investigational Site - Bradenton
- GSK Investigational Site - Chipley
- GSK Investigational Site - Daytona Beach
- GSK Investigational Site - Fort Myers
- GSK Investigational Site - Gainesville
- GSK Investigational Site - Marianna
- GSK Investigational Site - Miami Springs
- GSK Investigational Site - Naranja
- GSK Investigational Site - South Miami
- GSK Investigational Site - Tallahassee
- GSK Investigational Site - Tampa
- GSK Investigational Site - Tampa
California
- GSK Investigational Site - Oxnard
- GSK Investigational Site - Roseville
- GSK Investigational Site - San Francisco
Georgia
- GSK Investigational Site - Decatur
- GSK Investigational Site - Marietta
Arizona
- GSK Investigational Site - Phoenix
Illinois
- GSK Investigational Site - Chicago
Indiana
- GSK Investigational Site - Terre Haute
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00617461 record still lists
NCT00617461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Neuralgia, Postherpetic appearing as the primary indexed condition, and to 2 interventions - of which GEn 1200mg/day is the first listed.
NCT00617461 names 20 study sites across 6 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00617461 about?
NCT00617461 is a clinical study titled "A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment". The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.
What is the current status of trial NCT00617461?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2008-03. Estimated completion is 2009-07.
What conditions does trial NCT00617461 study?
This clinical trial studies the following conditions: Neuralgia, Postherpetic.
What interventions are being tested in trial NCT00617461?
The interventions under investigation include: GEn 1200mg/day (DRUG), GEn 3600mg/day (DRUG).
Who is sponsoring clinical trial NCT00617461?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00617461 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00617461's enrollment target sits among peer trials
96 747th of 2000 higher than 1,242 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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