Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

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 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).

Key facts

Study ID

NCT00251758

Run by

Takeda

People needed

908

Starts

2005-12-01

Expected to finish

2006-05-01

Last updated by the study team

2010-05-18

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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) or cyclo-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 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
• Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
• Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy

Where it is running

• Study site — Hueytown, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Tallassee, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Azusa, California, United States
• Study site — Carmichael, California, United States
• Study site — Cypress, California, United States
• Study site — Fresno, California, United States
• Study site — Los Angeles, California, United States
• Study site — Modesto, California, United States
• Study site — Newport Beach, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Maria, California, United States
• Study site — Littleton, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Bristol, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Fort Myers, Florida, United States
• Study site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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