Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Phase

Condition

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT00251758

T-GD04-083

U1111-1114-1811

Ages > 18
All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their mainsymptom as heartburn.
History of episodes of heartburn for 6 months or longer prior to screening.
History of episodes of heartburn for 4 or more days during the 7 days prior toDay -1 as recorded in the electronic diary.

Exclusion

Exclusion Criteria:

Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2)receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study
Erosive Esophagitis seen on endoscopy during study screening.
Co-existing diseases affecting the esophagus.
Abnormal laboratory values that suggest significant clinical disease.
Known acquired immunodeficiency syndrome (AIDS)
Females pregnant or lactating.
History of Alcohol abuse.
History of Cancer within 3 years prior to screening.
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
Need for continuous anticoagulant (blood thinner) therapy
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than a Schatzki's ring (a ringof mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretorycondition
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
Subjects who, in the opinion of the investigator, are unable to comply with therequirements of the study or are unsuitable for any reason.
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screeningendoscopy

Study Design

December 01, 2005

May 31, 2006

Study Description

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR (60 mg and 90 mg) 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 non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. 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.

Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (NCT00241745) and T-GD04-083 (this posting, NCT00251758), were combined and analyzed as a single larger study, referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.

Connect with a study center

Anniston, Alabama
United States
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Hueytown, Alabama
United States
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Huntsville, Alabama
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Tallassee, Alabama
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Tuscaloosa, Alabama
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Tucson, Arizona
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Little Rock, Arkansas
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North Little Rock, Arkansas
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Azusa, California
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Carmichael, California
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Cypress, California
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Fresno, California
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Los Angeles, California
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Modesto, California
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Newport Beach, California
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Oakland, California
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Orange, California
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San Diego, California
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Santa Maria, California
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Littleton, Colorado
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Longmont, Colorado
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Wheat Ridge, Colorado
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Bristol, Connecticut
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Newark, Delaware
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Fort Myers, Florida
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Miami, Florida
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Naples, Florida
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New Smyrna Beach, Florida
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Ocala, Florida
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Pembroke Pines, Florida
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Port Orange, Florida
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Saint Petersburg, Florida
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Sarasota, Florida
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Zephyrhills, Florida
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Atlanta, Georgia
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Champaign, Illinois
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Moline, Illinois
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North Chicago, Illinois
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Oak Forest, Illinois
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Springfield, Illinois
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Evansville, Indiana
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Indianapolis, Indiana
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Newburgh, Indiana
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Davenport, Iowa
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Kansas City, Kansas
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Wichita, Kansas
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Lexington, Kentucky
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Louisville, Kentucky
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Baton Rouge, Louisiana
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Chevy Chase, Maryland
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Prince Frederick, Maryland
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Jackson, Mississippi
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Jefferson City, Missouri
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Saint Louis, Missouri
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Missoula, Montana
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Egg Harbor Township, New Jersey
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Albuquerque, New Mexico
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Charlotte, North Carolina
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Greensboro, North Carolina
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High Point, North Carolina
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Raleigh, North Carolina
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Wilmington, North Carolina
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Winston Salem, North Carolina
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Bismarck, North Dakota
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Akron, Ohio
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Columbus, Ohio
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Dayton, Ohio
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Mogadore, Ohio
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Oklahoma City, Oklahoma
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Medford, Oregon
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Portland, Oregon
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Philadelphia, Pennsylvania
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Warwick, Rhode Island
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Anderson, South Carolina
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Mt. Pleasant, South Carolina
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Sioux Falls, South Dakota
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Chattanooga, Tennessee
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Germantown, Tennessee
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Johnson City, Tennessee
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Kingsport, Tennessee
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Amarillo, Texas
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Conroe, Texas
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Dallas, Texas
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Fort Worth, Texas
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Houston, Texas
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Odessa, Texas
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Pharr, Texas
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Seguin, Texas
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Temple, Texas
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Salt Lake City, Utah
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Charlottesville, Virginia
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Norfolk, Virginia
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Richmond, Virginia
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Bellevue, Washington
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Lakewood, Washington
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Tacoma, Washington
United States
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Milwaukee, Wisconsin
United States
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