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

Completed · Phase 3

Conditions studied: Gastroesophageal Reflux Disease

In brief

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.

Key facts

Study ID

NCT00255190

Run by

Takeda

People needed

591

Starts

2006-01-01

Expected to finish

2008-06-01

Last updated by the study team

2016-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Hueytown, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Tallassee, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Azusa, California, United States
• Study site — Carmichael, California, United States
• Study site — Chula Vista, California, United States
• Study site — Cypress, California, United States
• Study site — Fresno, California, United States
• Study site — Fullerton, California, United States
• Study site — Garden Grove, California, United States
• Study site — Irvine, California, United States
• Study site — Lancaster, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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