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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 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 460 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00978016
The ClinicalTrials.gov registry entry for NCT00978016 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XenoPort, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which arbaclofen placarbil-Cohort 1 is the first listed.
NCT00978016 reports 0 study locations.
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.
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