Back to resultsEfficiency Study of S-Tenatoprazole-Na to Treat Erosive or Ulcerative Esophagitis
Primary Purpose
Esophagitis, Reflux
Status
Suspended
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
S-Tenatoprazole-Na (STU-Na)
Sponsored by
About this trial
This is an interventional treatment trial for Esophagitis, Reflux focused on measuring Esophagitis, Reflux, S-Tenatoprazole-Na, Heartburn, Esophageal endoscopy
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00282555
Brief Title
Efficiency Study of S-Tenatoprazole-Na to Treat Erosive or Ulcerative Esophagitis
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 Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Suspended
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
STEBA France
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis, Reflux
Keywords
Esophagitis, Reflux, S-Tenatoprazole-Na, Heartburn, Esophageal endoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
S-Tenatoprazole-Na (STU-Na)
Primary Outcome Measure Information:
Title
Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after two weeks of treatment
Secondary Outcome Measure Information:
Title
Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after four weeks of treatment.
Title
Assessment of complete relief of heartburn
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Thomson, MD, Prof.
Organizational Affiliation
University of Alberta, Division of Gastroenterology, Department of Medicine, Edmonton, Alberta, Canada
Official's Role
Study Chair
Facility Information:
City
Calgary
State/Province
Alberta
Country
Canada
City
Edmonton
State/Province
Alberta
Country
Canada
City
Abbottsford
State/Province
British Columbia
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Guelph
State/Province
Ontario
Country
Canada
City
Hamilton
State/Province
Ontario
Country
Canada
City
Scarborough
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Lévis
State/Province
Quebec
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Pointe-Claire
State/Province
Quebec
Country
Canada
City
Sherbrooke
State/Province
Quebec
Country
Canada
City
St-Charles-de-Borromée
State/Province
Quebec
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
City
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
15456460
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
2142113
Citation
Burget DW, Chiverton SG, Hunt RH. Is there an optimal degree of acid suppression for healing of duodenal ulcers? A model of the relationship between ulcer healing and acid suppression. Gastroenterology. 1990 Aug;99(2):345-51. doi: 10.1016/0016-5085(90)91015-x.
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PubMed Identifier
10364004
Citation
DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. The Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1999 Jun;94(6):1434-42. doi: 10.1111/j.1572-0241.1999.1123_a.x. No abstract available.
Results Reference
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PubMed Identifier
15023167
Citation
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Citation
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PubMed Identifier
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Citation
Hunt RH, Armstrong D, James C, Chowdhury SK, Yuan Y, Fiorentini P, Taccoen A, Cohen P. Effect on intragastric pH of a PPI with a prolonged plasma half-life: comparison between tenatoprazole and esomeprazole on the duration of acid suppression in healthy male volunteers. Am J Gastroenterol. 2005 Sep;100(9):1949-56. doi: 10.1111/j.1572-0241.2005.41956.x.
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Efficiency Study of S-Tenatoprazole-Na to Treat Erosive or Ulcerative Esophagitis
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