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

Indivior

Status and phase: Completed; Phase 2

Conditions: GERD

Treatments: Drug: XP19986 CR; Drug: Placebo for XP19986 CR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838396

XP-B-049

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

XP19986 CR

Experimental group

Description:

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.

Treatment:

Drug: XP19986 CR

Placebo for XP19986 CR

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo for XP19986 CR