Status:
COMPLETED
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hea...
Detailed Description
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (30 mg QD and 60 mg...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
947 Patients enrolled
Trial Details
Trial ID
NCT00321984
Start Date
June 1 2006
End Date
December 1 2006
Last Update
April 28 2011
Active Locations (153)
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1
Alabaster, Alabama, United States
2
Birmingham, Alabama, United States
3
Hueytown, Alabama, United States
4
Huntsville, Alabama, United States