Status:
COMPLETED
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
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 daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of dayt...
Detailed Description
This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR (60 mg and 9...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
908 Patients enrolled
Trial Details
Trial ID
NCT00251758
Start Date
December 1 2005
End Date
May 1 2006
Last Update
May 18 2010
Active Locations (99)
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1
Anniston, Alabama, United States
2
Hueytown, Alabama, United States
3
Huntsville, Alabama, United States
4
Tallassee, Alabama, United States