Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

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.

Exclusion Criteria:

• 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.