Overview

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 GelusilĀ® )

- 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