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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

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.