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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.

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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

FieldValue
Enrollment Target 460 participants
Start Date 2009-09
Est. Completion 2010-12
Phase Phase 2

Sponsor

XenoPort

19 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.