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

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:

MedlinePlus related topics: Endoscopy Esophagus Disorders GERD Heartburn

U.S. FDA Resources

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

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:

Armstrong D. Review article: gastric pH -- the most relevant predictor of benefit in reflux disease? Aliment Pharmacol Ther. 2004 Oct;20 Suppl 5:19-26; discussion 38-9. Review.

Bell NJ, Burget D, Howden CW, Wilkinson J, Hunt RH. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion. 1992;51 Suppl 1:59-67.

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.

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. No abstract available.

Galmiche JP, Bruley Des Varannes S, Ducrotte P, Sacher-Huvelin S, Vavasseur F, Taccoen A, Fiorentini P, Homerin M. Tenatoprazole, a novel proton pump inhibitor with a prolonged plasma half-life: effects on intragastric pH and comparison with esomeprazole in healthy volunteers. Aliment Pharmacol Ther. 2004 Mar 15;19(6):655-62.

Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000 Mar;22(3):266-80; discussion 265. Review.

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.

Kakinoki B, Ono C, Yamazaki N, Chikamatsu N, Wakatsuki D, Uchiyama K, Morinaka Y. General pharmacological properties of the new proton pump inhibitor (+/-)-5-methoxy-2-[[(4-methoxy-3,5-dimethylpyrid-2-yl)methyl]sulf inyl]- 1H-imidazo[4,5-b]pyridine. Methods Find Exp Clin Pharmacol. 1999 Apr;21(3):179-87.

Katz PO, Castell DO, Chen Y, Andersson T, Sostek MB. Intragastric acid suppression and pharmacokinetics of twice-daily esomeprazole: a randomized, three-way crossover study. Aliment Pharmacol Ther. 2004 Aug 15;20(4):399-406.

Kromer W, Horbach S, Luhmann R. Relative efficacies of gastric proton pump inhibitors: their clinical and pharmacological basis. Pharmacology. 1999 Aug;59(2):57-77. Review.

Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80.

Revicki DA, Crawley JA, Zodet MW, Levine DS, Joelsson BO. Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1999 Dec;13(12):1621-30.

Stedman CA, Barclay ML. Review article: comparison of the pharmacokinetics, acid suppression and efficacy of proton pump inhibitors. Aliment Pharmacol Ther. 2000 Aug;14(8):963-78. Review.

Uchiyama K, Wakatsuki D, Kakinoki B, Takeuchi Y, Araki T, Morinaka Y. The long-lasting effect of TU-199, a novel H+, K(+)-ATPase inhibitor, on gastric acid secretion in dogs. J Pharm Pharmacol. 1999 Apr;51(4):457-64.

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 May 22, 2013