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

NCT00838396 | Completed Phase 2

• 1 other identifier: XP-B-049
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: XP19986 CR

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.

Drug: Placebo for XP19986 CR

Interventions

XP19986 CR DRUG

Also known as: Eudragit RL 100

XP19986 CR

Placebo for XP19986 CR DRUG

Also known as: Sugar Pill

Placebo for XP19986 CR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (3)

Unknown Facility

Stanford, California, 94305, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Tacoma, Washington, 98403, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Eudragit RS; Sugars

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Jay Huff, M.D.

  XenoPort, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: October 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)