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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00838396
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):

February 5, 2009
February 6, 2009
September 14, 2016
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 ]
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 ]
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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
GERD
  • Drug: XP19986 CR
    Other Name: Eudragit RL 100
  • Drug: Placebo for XP19986 CR
    Other Name: Sugar Pill
  • 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.
    Intervention: Drug: XP19986 CR
  • 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.
    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.)
Sexes Eligible for Study: All
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
Plan to Share IPD: No
Indivior Inc.
Indivior Inc.
Not Provided
Study Director: Jay Huff, M.D. XenoPort, Inc.
Indivior Inc.
September 2016

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