A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease

September 12, 2016 updated by: Indivior Inc.

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover, Single Dose-Finding Study to Assess the Efficacy and Safety of Controlled Release XP19986 in Patients With Gastroesophageal Reflux Disease

The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil (XP19986) compared to placebo in patients with gastroesophageal reflux disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Washington
      • Tacoma, Washington, United States, 98403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week
  2. Discontinuation of drugs used to treat GERD (PPIs, H2-blockers) and/or drugs known to cause GERD symptoms (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs]) for 7 days prior to baseline (Visit 2);
  3. Had greater then or equal to 20 postprandial reflux episodes/2 hours recorded using impedance/pH monitoring during Screening/Baseline period (Visit 2)

Exclusion Criteria:

  1. History of gastrointestinal disorders other than GERD that may have significantly affected the assessment of reflux episodes or GERD symptoms (e.g. Barrett's Esophagus, active gastric or duodenal ulcer disease, achalasia, scleroderma, etc.).
  2. Medical conditions that could have affected assessments of reflux episodes or GERD symptoms (e.g. history of nausea and/or vomiting, neurologic/psychiatric disorders, cardiac disease [e.g. angina], lung disease [e.g. asthma, cough], etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XP19986 CR
On either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of XP19986 10, 20, 40 or 60 mg.
Drug: XP19986 CR
Other Names:
  • Eudragit RL 100
Placebo Comparator: Placebo for XP19986 CR
On either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of placebo.
Drug: Placebo for XP19986 CR
Other Names:
  • Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy assessment endpoint of this study was the total number of reflux episodes (acid and non-acid) comparing study drug to placebo
Time Frame: 12 hours
12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Reflux episodes (acid and non-acid) during each treatment period at various time intervals, dose/exposure to reflux rate relationship, acid reflux events, non-acid reflux events, and GERD symptoms.
Time Frame: 12 hours
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indivior Inc.

Investigators

  • Study Director: Jay Huff, M.D., XenoPort, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XP-B-049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on GERD

Clinical Trials on XP19986 CR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe