Status:
COMPLETED
Safety and Quality of Life Study 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 determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Detailed Description
This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal refl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Any condition that may require inpatient surgery during the course of the study.
- Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
- Use of antacids \[except for study supplied Gelusil®\].
- Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
- Evidence of uncontrolled systemic disease.
- Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
- Need to take blood thinners.
- Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
- Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
- Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
- Has had radiation or cryotherapy to the esophagus.
- Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
- Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
- History of alcohol abuse.
- Has acquired immunodeficiency syndrome.
- Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
- Received a blood product transfusion within 3 months of taking the first dose of study drug.
- Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
591 Patients enrolled
Trial Details
Trial ID
NCT00255190
Start Date
January 1 2006
End Date
June 1 2008
Last Update
July 27 2016
Active Locations (181)
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1
Alabaster, Alabama, United States
2
Anniston, Alabama, United States
3
Birmingham, Alabama, United States
4
Hueytown, Alabama, United States