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

GERD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838396
• Other study ID #: XP-B-049
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2009
• Last updated: September 12, 2016
• Start date: October 2005
• Est. completion date: August 2006

Study information

• Verified date: September 2016
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• XP19986 CR

• Placebo for XP19986 CR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy assessment endpoint of this study was the total number of reflux episodes (acid and non-acid) comparing study drug to placebo		12 hours	No
Secondary	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.		12 hours	No