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Sponsored by: |
STEBA France |
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Information provided by: | STEBA France |
ClinicalTrials.gov Identifier: | NCT00282555 |
STU-Na belongs to the proton pump inhibitors (PPI), a group of drugs that reduce gastric acidity. PPI are used to treat acid related diseases like erosive or ulcerative esophagitis. This trial aims to find out the therapeutic dose of STU-Na required for healing patients with erosive or ulcerative esophagitis. One of four dosages of STU-Na (15 mg, 30 mg, 60 mg, or 90 mg daily), or Esomeprazole 40 mg daily, an already marketed PPI, will be given to patients. The attribution to one of the 5 treatment groups will be by chance. Neither the patient nor the study physician will know, which treatment is administered to the patient.
Condition | Intervention | Phase |
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Esophagitis, Reflux |
Drug: S-Tenatoprazole-Na (STU-Na) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Assessment of the Healing Rate of Erosive or Ulcerative Esophagitis After Two and Four Weeks of Treatment With S-Tenatoprazole-Na (STU-Na) 15 mg, 30 mg, 60 mg, 90 mg and Esomeprazole 40 mg. A Multicenter, Randomized, Double-Blind, Parallel Group Study. |
Estimated Enrollment: | 450 |
Study Start Date: | February 2006 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
Quebec, Canada | |
Canada, Alberta | |
Calgary, Alberta, Canada | |
Edmonton, Alberta, Canada | |
Canada, British Columbia | |
Vancouver, British Columbia, Canada | |
Abbottsford, British Columbia, Canada | |
Canada, Manitoba | |
Winnipeg, Manitoba, Canada | |
Canada, Ontario | |
Toronto, Ontario, Canada | |
Scarborough, Ontario, Canada | |
Hamilton, Ontario, Canada | |
Windsor, Ontario, Canada | |
Toronto, Ontario, Canada | |
Guelph, Ontario, Canada | |
Canada, Quebec | |
Montreal, Quebec, Canada | |
St-Charles-de-Borromée, Quebec, Canada | |
Pointe-Claire, Quebec, Canada | |
Sherbrooke, Quebec, Canada | |
Lévis, Quebec, Canada | |
Canada, Saskatchewan | |
Saskatoon, Saskatchewan, Canada |
Study Chair: | Alan Thomson, MD, Prof. | University of Alberta, Division of Gastroenterology, Department of Medicine, Edmonton, Alberta, Canada |
Study ID Numbers: | HEC/STU(-Na)05816N/TU 2.05 |
Study First Received: | January 25, 2006 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00282555 |
Health Authority: | Canada: Health Canada |
Esophagitis, Reflux S-Tenatoprazole-Na Heartburn Esophageal endoscopy |
Esophagitis Pyrosis Esophagitis, Peptic Digestive System Diseases Esophageal disorder Gastrointestinal Diseases |
Ulcer Heartburn Omeprazole Esophageal Diseases Gastroenteritis Peptic Ulcer |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |