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NCT00619476 · ClinicalTrials.gov registry record · Phase 2
A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN)
A Phase 2 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 376
- Enrollment target
NCT00619476: Completed Phase 2 study, sponsored by XenoPort.
NCT00619476 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 376 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (183% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00619476, a Phase 2 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 376 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN).
Primary Outcome
Baseline and EOMT 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 earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their average pain intensity 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 provi
Interventions
- DRUG Placebo
- DRUG GEn 1200mg/day
- DRUG GEn 3600mg/day
- DRUG GEn 2400mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00619476 record still lists
NCT00619476 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (183% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00619476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00619476 about?
NCT00619476 is a clinical study titled "A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN)". The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN).
What is the current status of trial NCT00619476?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 376 participants. The study started on 2008-02. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00619476?
The interventions under investigation include: Placebo (DRUG), GEn 1200mg/day (DRUG), GEn 3600mg/day (DRUG), GEn 2400mg/day (DRUG).
Who is sponsoring clinical trial NCT00619476?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00619476's enrollment target sits among peer trials
376 116th of 2000 higher than 1,885 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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