Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Launched by TAKEDA · May 2, 2006
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).
- • Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
- • Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.
- Exclusion Criteria:
- • Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.
- • Subjects with erosive esophagitis (EE) as shown by endoscopy.
- • Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. 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 of Dexlansoprazole MR, or antacid.
- • Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
- • Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-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 the requirements of the study or are unsuitable for any reason.
About Takeda
Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Tucson, Arizona, United States
San Francisco, California, United States
Miami, Florida, United States
Baltimore, Maryland, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Dallas, Texas, United States
Birmingham, Alabama, United States
Orange, California, United States
San Diego, California, United States
Lexington, Kentucky, United States
Great Neck, New York, United States
Greensboro, North Carolina, United States
Boise, Idaho, United States
Las Vegas, Nevada, United States
Anaheim, California, United States
Chula Vista, California, United States
Sioux Falls, South Dakota, United States
Austin, Texas, United States
El Paso, Texas, United States
Salt Lake City, Utah, United States
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Conroe, Texas, United States
Wichita, Kansas, United States
Oklahoma City, Oklahoma, United States
Tacoma, Washington, United States
Huntsville, Alabama, United States
Fountain Valley, California, United States
Fullerton, California, United States
Lancaster, California, United States
Louisville, Kentucky, United States
Charleston, South Carolina, United States
Johnson City, Tennessee, United States
Fort Worth, Texas, United States
Baton Rouge, Louisiana, United States
West Palm Beach, Florida, United States
Lake Jackson, Texas, United States
Chattanooga, Tennessee, United States
Chesapeake, Virginia, United States
Vista, California, United States
Charlottesville, Virginia, United States
Spokane, Washington, United States
Saint Petersburg, Florida, United States
Raleigh, North Carolina, United States
Dayton, Ohio, United States
Bristol, Tennessee, United States
Kingsport, Tennessee, United States
Amarillo, Texas, United States
Jackson, Mississippi, United States
Jefferson City, Missouri, United States
Honolulu, Hawaii, United States
Metairie, Louisiana, United States
Chevy Chase, Maryland, United States
Mexico, Missouri, United States
Duncansville, Pennsylvania, United States
Colorado Springs, Colorado, United States
Pasadena, California, United States
Oakland, California, United States
Garden Grove, California, United States
Conyers, Georgia, United States
Butte, Montana, United States
Wheat Ridge, Colorado, United States
Medford, Oregon, United States
Ogden, Utah, United States
Palm Springs, California, United States
San Luis Obispo, California, United States
Littleton, Colorado, United States
Clive, Iowa, United States
Troy, Michigan, United States
Northport, Alabama, United States
Sun City, Arizona, United States
Ocala, Florida, United States
Holly Hill, Florida, United States
Alabaster, Alabama, United States
Germantown, Tennessee, United States
Charlotte, North Carolina, United States
Chaska, Minnesota, United States
Mogadore, Ohio, United States
Naples, Florida, United States
Lyndhurst, Ohio, United States
Pembroke Pines, Florida, United States
Statesville, North Carolina, United States
Lakewood, Washington, United States
Carmichael, California, United States
Waterbury, Connecticut, United States
Kissimmee, Florida, United States
Irvine, California, United States
Beaumont, Texas, United States
High Point, North Carolina, United States
Westlake Village, California, United States
Cypress, California, United States
Olive Branch, Mississippi, United States
Lansdale, Pennsylvania, United States
Anderson, South Carolina, United States
Mount Pleasant, South Carolina, United States
Zephyrhills, Florida, United States
Boulder, Colorado, United States
Tallassee, Alabama, United States
Boynton Beach, Florida, United States
Rockford, Illinois, United States
Hermitage, Tennessee, United States
Bryan, Texas, United States
Dunwoody, Georgia, United States
Mission Hills, California, United States
Redwood City, California, United States
Lone Tree, Colorado, United States
Dubuque, Iowa, United States
Hollywood, Maryland, United States
Lutherville, Maryland, United States
Washington, Missouri, United States
Pahrump, Nevada, United States
Binghamton, New York, United States
Corsicana, Texas, United States
Monroe, Wisconsin, United States
Hueytown, Alabama, United States
Azusa, California, United States
Moline, Illinois, United States
Prince Frederick, Maryland, United States
Chandler, Arizona, United States
Bismark, North Dakota, United States
Harrisburg, California, United States
New Smyma Beach, Florida, United States
Oak Forrest, Illinois, United States
North Little Rock, Arizona, United States
Tempe, Arizona, United States
Clearwater, California, United States
Jupitor, Florida, United States
Stockbridge, Georgia, United States
Overland, Kansas, United States
Egg Harbor Town, New Jersey, United States
Franklin, Ohio, United States
Sylvania, Ohio, United States
Harleysville, Pennsylvania, United States
Levittown, Pennsylvania, United States
Varnville, South Carolina, United States
Bellaire, Texas, United States
Carollton, Texas, United States
Midvale, Utah, United States
Norfold, Virginia, United States
Patients applied
Trial Officials
Medical Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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