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NCT00978016 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
A Phase 2 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 460
- Enrollment target
NCT00978016: Completed Phase 2 study, sponsored by XenoPort.
NCT00978016 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 460 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (246% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00978016, a Phase 2 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 460 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite therapy with approved doses of a Proton Pump Inhibitor (PPI).
Primary Outcome
number of episodes
Interventions
- DRUG arbaclofen placarbil-Cohort 1
- DRUG Placebo-Cohort 5
- DRUG arbaclofen placarbil-Cohort 2
- DRUG arbaclofen placarbil-Cohort 3
- DRUG arbaclofen placarbil-Cohort 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT00978016 record still lists
NCT00978016 is an interventional study that assigns participants to a tested intervention. The registered 460 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 (246% higher).
The record links to 0 conditions, and to 5 interventions - of which arbaclofen placarbil-Cohort 1 is the first listed.
NCT00978016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00978016 about?
NCT00978016 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)". The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite therapy with approved doses of a Proton Pump Inhibitor (PPI).
What is the current status of trial NCT00978016?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 460 participants. The study started on 2009-09. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00978016?
The interventions under investigation include: arbaclofen placarbil-Cohort 1 (DRUG), Placebo-Cohort 5 (DRUG), arbaclofen placarbil-Cohort 2 (DRUG), arbaclofen placarbil-Cohort 3 (DRUG), arbaclofen placarbil-Cohort 4 (DRUG).
Who is sponsoring clinical trial NCT00978016?
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 NCT00978016's enrollment target sits among peer trials
460 83rd of 2000 higher than 1,917 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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