Overview

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 GelusilĀ®].

- 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.