Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

• Lead Sponsor: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

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

• 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