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

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease

In brief

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).

Key facts

Study ID

NCT00321984

Run by

Takeda

People needed

947

Starts

2006-06-01

Expected to finish

2006-12-01

Last updated by the study team

2011-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Hueytown, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Northport, Alabama, United States
• Study site — Tallassee, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — North Little Rock, Arizona, United States
• Study site — Sun City, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Azusa, California, United States
• Study site — Carmichael, California, United States
• Study site — Chula Vista, California, United States
• Study site — Clearwater, California, United States
• Study site — Cypress, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Fullerton, California, United States
• Study site — Garden Grove, California, United States
• Study site — Irvine, California, United States
• Study site — Lancaster, California, United States
• Study site — Mission Hills, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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