Trial | NCT00838396  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    GERD

  • Intervention/Treatment

    arbaclofen ...

  • Study Participants

    58
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 Started
Oct 31
2005
Primary Completion
Aug 31
2006
Study Completion
Aug 31
2006
Last Update
Sep 14
2016
Estimate

Drug XP19986 CR

  • Other names: Eudragit RL 100

Drug Placebo for XP19986 CR

  • Other names: Sugar Pill

XP19986 CR Experimental

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.

Placebo for XP19986 CR Placebo Comparator

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.

Criteria 

Inclusion Criteria:

History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week
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);
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:

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.).
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.)
No Results Posted