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

March 18, 2008 updated by: STEBA France

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.

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Abbottsford, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Guelph, Ontario, Canada
      • Hamilton, Ontario, Canada
      • Scarborough, Ontario, Canada
      • Toronto, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • Lévis, Quebec, Canada
      • Montreal, Quebec, Canada
      • Pointe-Claire, Quebec, Canada
      • Sherbrooke, Quebec, Canada
      • St-Charles-de-Borromée, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

STEBA France

Investigators

  • Study Chair: Alan Thomson, MD, Prof., University of Alberta, Division of Gastroenterology, Department of Medicine, Edmonton, Alberta, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Registration Dates

First Submitted

January 25, 2006

First Submitted That Met QC Criteria

January 25, 2006

First Posted (Estimate)

January 26, 2006

Study Record Updates

Last Update Posted (Estimate)

March 19, 2008

Last Update Submitted That Met QC Criteria

March 18, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEC/STU(-Na)05816N/TU 2.05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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