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NCT00643760 · ClinicalTrials.gov registry record · Phase 2
A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)
A Phase 2 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 421
- Enrollment target
NCT00643760: Completed Phase 2 study, sponsored by XenoPort.
NCT00643760 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 421 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (217% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00643760, a Phase 2 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 421 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 diabetic peripheral neuropathy(DPN)
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 API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were pro
Interventions
- DRUG Placebo
- DRUG Pregabalin
- DRUG GEn 1200mg/day
- DRUG GEn 3600mg/day
- DRUG GEn 2400mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 421 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-02 |
| Phase | Phase 2 |
What the finished NCT00643760 record still lists
NCT00643760 is an interventional study that assigns participants to a tested intervention. The registered 421 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 (217% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00643760 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00643760 about?
NCT00643760 is a clinical study titled "A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)". 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 diabetic peripheral neuropathy(DPN)
What is the current status of trial NCT00643760?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 421 participants. The study started on 2008-03. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00643760?
The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG), GEn 1200mg/day (DRUG), GEn 3600mg/day (DRUG), GEn 2400mg/day (DRUG).
Who is sponsoring clinical trial NCT00643760?
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 NCT00643760's enrollment target sits among peer trials
421 91st of 2000 higher than 1,910 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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