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Efficiency Study of S-Tenatoprazole-Na to Treat Erosive or Ulcerative Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00282555
Recruitment Status : Suspended
First Posted : January 26, 2006
Last Update Posted : March 19, 2008
Information provided by:
STEBA France

Brief Summary:
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 or disease Intervention/treatment Phase
Esophagitis, Reflux Drug: S-Tenatoprazole-Na (STU-Na) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : February 2006

Primary Outcome Measures :
  1. Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after two weeks of treatment

Secondary Outcome Measures :
  1. Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after four weeks of treatment.
  2. Assessment of complete relief of heartburn

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female outpatients aged 18 to 75 years inclusive
  • Symptomatic ulcerative or erosive esophagitis
  • Presence of heartburn (daytime and/or nighttime).
  • Understanding the study and agreeing to give a written informed consent
  • Able to communicate well with the investigator him(her)self or his/her representatives
  • Able and agreeing to comply with all study requirements

Exclusion Criteria:

  • gastrointestinal bleeding
  • gastric or esophageal surgery
  • Zollinger-Ellison syndrome
  • primary esophageal motility disorders,
  • esophageal stricture,
  • inflammatory bowel disease,
  • upper gastrointestinal malignancy,
  • pancreatitis,
  • malabsorption
  • Barrett's esophagus (> 3 cm)
  • Severe disease/condition such as malignancy
  • Hypersensitivity to PPIs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00282555

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Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Abbottsford, British Columbia, Canada
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Guelph, Ontario, Canada
Hamilton, Ontario, Canada
Scarborough, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Canada, Quebec
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Sherbrooke, Quebec, Canada
St-Charles-de-Borromée, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Quebec, Canada
Sponsors and Collaborators
STEBA France
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Study Chair: Alan Thomson, MD, Prof. University of Alberta, Division of Gastroenterology, Department of Medicine, Edmonton, Alberta, Canada

Layout table for additonal information Identifier: NCT00282555    
Other Study ID Numbers: HEC/STU(-Na)05816N/TU 2.05
First Posted: January 26, 2006    Key Record Dates
Last Update Posted: March 19, 2008
Last Verified: March 2008
Keywords provided by STEBA France:
Esophagitis, Reflux
Esophageal endoscopy
Additional relevant MeSH terms:
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Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases