Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Recruiting in Palo Alto (17 mi)
+177 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Takeda
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Eligibility Criteria
Inclusion Criteria
Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.
Treatment Details
Interventions
- Dexlansoprazole MR (Proton Pump Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Dexlansoprazole MR 90 mg QDExperimental Treatment1 Intervention
Group II: Dexlansoprazole MR 60 mg QDExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00255190St. Petersburg, FL
NCT00255190Dubuque, IA
NCT00255190Shreveport, LA
NCT00255190Pahrump, NV
More Trial Locations
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Who Is Running the Clinical Trial?
TakedaLead Sponsor