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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
STEBA France
ClinicalTrials.gov Identifier:
NCT00282555
First received: January 25, 2006
Last updated: March 18, 2008
Last verified: March 2008
  Purpose

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
Esophagitis, Reflux
Drug: S-Tenatoprazole-Na (STU-Na)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by STEBA France:

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

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

Estimated Enrollment: 450
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282555

Locations
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
Canada
Quebec, Canada
Sponsors and Collaborators
STEBA France
Investigators
Study Chair: Alan Thomson, MD, Prof. University of Alberta, Division of Gastroenterology, Department of Medicine, Edmonton, Alberta, Canada
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00282555     History of Changes
Other Study ID Numbers: HEC/STU(-Na)05816N/TU 2.05
Study First Received: January 25, 2006
Last Updated: March 18, 2008
Health Authority: Canada: Health Canada

Keywords provided by STEBA France:
Esophagitis, Reflux
S-Tenatoprazole-Na
Heartburn
Esophageal endoscopy

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014