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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.
ClinicalTrials.gov Identifier:
NCT00838396
First received: February 5, 2009
Last updated: December 30, 2015
Last verified: December 2015

February 5, 2009
December 30, 2015
October 2005
August 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00838396 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
GERD
  • Drug: XP19986 CR
    On study Day 1, patients received a single dose of XP19986 10, 20, 40 or 60 mg or placebo. On study Day 5, after completion of the minimum 3-day washout period, patients crossed over to the other treatment and received a single dose of XP19986 CR or matching Placebo. XP19986 CR was administered as a single dose of 10, 20, 40, or 60 mg.
    Other Name: Eudragit RL 100
  • Drug: Placebo for XP19986 CR
    On study Day 1, patients received a single dose of XP19986 10, 20, 40 or 60 mg or placebo. On study Day 5, after completion of the minimum 3-day washout period, patients crossed over to the other treatment and received a single dose of XP19986 CR or matching Placebo. XP19986 CR was administered as a single dose of 10, 20, 40, or 60 mg.
    Other Name: Sugar Pill
  • Experimental: XP19986 CR
    On study Day 1, patients received a single dose of XP19986 10, 20, 40 or 60 mg or placebo. On study Day 5, after completion of the minimum 3-day washout period, patients crossed over to the other treatment and received a single dose of XP19986 CR or matching Placebo. XP19986 CR was administered as a single dose of 10, 20, 40, or 60 mg.
    Intervention: Drug: XP19986 CR
  • Placebo Comparator: Placebo for XP19986 CR
    On study Day 1, patients received a single dose of XP19986 10, 20, 40 or 60 mg or placebo. On study Day 5, after completion of the minimum 3-day washout period, patients crossed over to the other treatment and received a single dose of XP19986 CR or matching Placebo. XP19986 CR was administered as a single dose of 10, 20, 40, or 60 mg.
    Intervention: Drug: Placebo for XP19986 CR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
August 2006
August 2006   (final data collection date for primary outcome measure)

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.)
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00838396
XP-B-049
No
Not Provided
Not Provided
Indivior Inc.
Indivior Inc.
Not Provided
Study Director: Jay Huff, M.D. XenoPort, Inc.
Indivior Inc.
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP