Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

Phase

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00321984

T-GD05-137

2006-000420-13

U1111-1114-1935

Ages > 18
All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects identifying their main symptom as a burning feeling in the mid epigastricarea and/or chest area (ie, heartburn).
Subject has a history of episodes of heartburn for 6 months or longer prior toScreening.
Subject must have a history of episodes of heartburn for 4 or more days during the 7days prior to Day -1.

Exclusion

Exclusion Criteria:

Endoscopic Barrett's esophagus and/or definite dysplastic changes. History ofdilatation of esophageal strictures.
Subjects with erosive esophagitis (EE) as shown by endoscopy.
Evidence of uncontrolled systemic disease. Co-existing diseases affecting theesophagus. Current or history of Zollinger-Ellison syndrome.
Subject has abnormal laboratory values.
Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
Subject known to have acquired immunodeficiency syndrome (AIDS).
Known hypersensitivity to any proton pump inhibitor (PPI), any component ofDexlansoprazole MR, or antacid.
Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, orsucralfate.
Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) orcyclo-oxygenase-2 (COX-2) inhibitors.
Use of antacids (except for study-supplied Gelusil® ).
Use of drugs with significant anticholinergic effects.
Subjects who cannot discontinue the use of misoprostol or prokinetics
Need for continuous anticoagulant therapy.
Females who are pregnant or lactating.
History of gastrointestinal surgery except for simple oversew of ulcer.
History of cancer within 3 years prior to screening.
Subject has participated in a previous Dexlansoprazole study.
Subjects who, in the opinion of the investigator, are unable to comply with therequirements of the study or are unsuitable for any reason.

Study Design

June 01, 2006

December 31, 2006

Study Description

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg QD) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US sites. The study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Connect with a study center

Alabaster, Alabama
United States
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Birmingham, Alabama
United States
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Hueytown, Alabama
United States
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Huntsville, Alabama
United States
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Northport, Alabama
United States
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Tallassee, Alabama
United States
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Chandler, Arizona
United States
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North Little Rock, Arizona
United States
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Sun City, Arizona
United States
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Tempe, Arizona
United States
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Tucson, Arizona
United States
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Anaheim, California
United States
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Azusa, California
United States
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Carmichael, California
United States
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Chula Vista, California
United States
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Clearwater, California
United States
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Cypress, California
United States
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Fountain Valley, California
United States
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Fullerton, California
United States
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Garden Grove, California
United States
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Irvine, California
United States
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Lancaster, California
United States
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Mission Hills, California
United States
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Oakland, California
United States
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Orange, California
United States
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Palm Springs, California
United States
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Pasadena, California
United States
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Redwood City, California
United States
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San Diego, California
United States
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San Francisco, California
United States
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San Luis Obispo, California
United States
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Vista, California
United States
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Westlake Village, California
United States
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Boulder, Colorado
United States
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Colorado Springs, Colorado
United States
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Littleton, Colorado
United States
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Lone Tree, Colorado
United States
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Wheat Ridge, Colorado
United States
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Bristol, Connecticut
United States
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Waterbury, Connecticut
United States
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Boynton Beach, Florida
United States
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Holly Hill, Florida
United States
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Jupitor, Florida
United States
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Kissimmee, Florida
United States
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Miami, Florida
United States
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Naples, Florida
United States
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New Smyma Beach, Florida
United States
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Ocala, Florida
United States
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Pembroke Pines, Florida
United States
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Saint Petersburg, Florida
United States
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West Palm Beach, Florida
United States
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Zephyrhills, Florida
United States
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Atlanta, Georgia
United States
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Conyers, Georgia
United States
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Dunwoody, Georgia
United States
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Stockbridge, Georgia
United States
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Honolulu, Hawaii
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Boise, Idaho
United States
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Moline, Illinois
United States
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Oak Forrest, Illinois
United States
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Rockford, Illinois
United States
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Indianapolis, Indiana
United States
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Clive, Iowa
United States
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Dubuque, Iowa
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Overland, Kansas
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Wichita, Kansas
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Lexington, Kentucky
United States
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Louisville, Kentucky
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Baton Rouge, Louisiana
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Metairie, Louisiana
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Baltimore, Maryland
United States
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Chevy Chase, Maryland
United States
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Hollywood, Maryland
United States
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Lutherville, Maryland
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Prince Frederick, Maryland
United States
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Troy, Michigan
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Chaska, Minnesota
United States
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Olive Branch, Mississippi
United States
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Jefferson City, Missouri
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Mexico, Missouri
United States
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Washington, Missouri
United States
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Butte, Montana
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Las Vegas, Nevada
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Pahrump, Nevada
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Egg Harbor Town, New Jersey
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Albuquerque, New Mexico
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Binghamton, New York
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Great Neck, New York
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Rochester, New York
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Charlotte, North Carolina
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Greensboro, North Carolina
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Harrisburg, North Carolina
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High Point, North Carolina
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Raleigh, North Carolina
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Statesville, North Carolina
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Bismark, North Dakota
United States
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Cincinnati, Ohio
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Cleveland, Ohio
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Columbus, Ohio
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Dayton, Ohio
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Franklin, Ohio
United States
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Kettering, Ohio
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Lyndhurst, Ohio
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Mogadore, Ohio
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Sylvania, Ohio
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Oklahoma City, Oklahoma
United States
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Medford, Oregon
United States
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Portland, Oregon
United States
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Duncansville, Pennsylvania
United States
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Harleysville, Pennsylvania
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Lansdale, Pennsylvania
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Levittown, Pennsylvania
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Anderson, South Carolina
United States
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Charleston, South Carolina
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Mount Pleasant, South Carolina
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Varnville, South Carolina
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Sioux Falls, South Dakota
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Chattanooga, Tennessee
United States
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Germantown, Tennessee
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Hermitage, Tennessee
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Jackson, Tennessee
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Johnson City, Tennessee
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Kingsport, Tennessee
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Nashville, Tennessee
United States
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Amarillo, Texas
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Austin, Texas
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Beaumont, Texas
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Bellaire, Texas
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Bryan, Texas
United States
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Carollton, Texas
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Conroe, Texas
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Corsicana, Texas
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Dallas, Texas
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El Paso, Texas
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Fort Worth, Texas
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Houston, Texas
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Lake Jackson, Texas
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San Antonio, Texas
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Midvale, Utah
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Ogden, Utah
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Salt Lake City, Utah
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Charlottesville, Virginia
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Chesapeake, Virginia
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Norfold, Virginia
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Richmond, Virginia
United States
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Lakewood, Washington
United States
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Spokane, Washington
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Tacoma, Washington
United States
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Milwaukee, Wisconsin
United States
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Monroe, Wisconsin
United States
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