- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00251745
Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 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 (this posting, NCT00241745) and T-GD04-083 (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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Alabaster, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Arizona
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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California
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Anaheim, California, United States
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Chula Vista, 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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Long Beach, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Palm Springs, 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 Luis Obispo, California, United States
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San Marino, California, United States
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Colorado
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Boulder, Colorado, United States
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Colorado Springs, 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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Connecticut
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Waterbury, Connecticut, United States
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Florida
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Boynton Beach, Florida, United States
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Jacksonsville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Lakeland, Florida, United States
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New Port Richey, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Hawaii
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Honolulu, Hawaii, United States
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Illinois
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Hines, Illinois, United States
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Oak Park, Illinois, United States
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Rockford, Illinois, United States
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Iowa
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Clive, Iowa, United States
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Dubuque, Iowa, United States
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Kansas
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Newton, Kansas, United States
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Shawnee Mission, Kansas, United States
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Topeka, Kansas, United States
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Louisiana
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Maryland
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Hollywood, Maryland, United States
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Lutherville, Maryland, United States
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Michigan
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Troy, Michigan, United States
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Minnesota
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Chaska, Minnesota, United States
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Mississippi
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Jackson, Mississippi, United States
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Missouri
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Mexico, Missouri, United States
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Saint Louis, Missouri, United States
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Washington, Missouri, United States
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Nebraska
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Omaha, Nebraska, United States
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Nevada
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Pahrump, Nevada, United States
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New Jersey
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New Brunswick, New Jersey, United States
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New York
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Binghamton, New York, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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Rochester, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Elkin, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Salisbury, North Carolina, United States
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Statesville, North Carolina, United States
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Winston Salem, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Mayfield Heights, Ohio, United States
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Warren, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Beaver Falls, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Tennessee
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Hermitage, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bryan, Texas, United States
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Corsicana, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Utah
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Bountiful, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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Virginia
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Chesapeake, Virginia, United States
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Danville, Virginia, United States
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Washington
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Spokane, Washington, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Monroe, Wisconsin, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom 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 to Day -1 as recorded in the electronic diary.
Exclusion Criteria:
- Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study·
- 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 ring of mucosal tissue near the lower esophageal sphincter).
- Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
- History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
- Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy.
- 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) or cyclo-oxygenase-2 (COX-2) inhibitors
- Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
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Experimental: Dexlansoprazole MR 60 mg QD
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Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
Other Names:
Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
Other Names:
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Experimental: Dexlansoprazole MR 90 mg QD
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Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
Other Names:
Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Time Frame: 4 weeks
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The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
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4 weeks
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Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Time Frame: 4 weeks
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The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Time Frame: 4 weeks
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The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
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4 weeks
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Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Time Frame: 4 weeks
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The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
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4 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dexlansoprazole
- Lansoprazole
Other Study ID Numbers
- T-GD04-082
- U1111-1114-0144 (Registry Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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