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NCT00817986 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
A Phase 2 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
NCT00817986: Completed Phase 2 study, sponsored by XenoPort.
NCT00817986 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 161 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00817986, a Phase 2 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.
Primary Outcome
Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs
Interventions
- DRUG Placebo
- DRUG Arbaclofen placarbil, 20 mg
- DRUG Arbaclofen placarbil, 30 mg
- DRUG Arbaclofen placarbil, 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00817986 record still lists
NCT00817986 is an interventional study that assigns participants to a tested intervention. The registered 161 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 (21% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00817986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00817986 about?
NCT00817986 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms". The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.
What is the current status of trial NCT00817986?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2008-12. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00817986?
The interventions under investigation include: Placebo (DRUG), Arbaclofen placarbil, 20 mg (DRUG), Arbaclofen placarbil, 30 mg (DRUG), Arbaclofen placarbil, 40 mg (DRUG).
Who is sponsoring clinical trial NCT00817986?
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 NCT00817986's enrollment target sits among peer trials
161 422nd of 2000 higher than 1,579 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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