Clinical trial NCT00282555: 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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Esophagitis, Reflux
Keywords: Esophagitis, Reflux
S-Tenatoprazole-Na
Heartburn
Esophageal endoscopy
Lead sponsor: STEBA France
Sponsor class: INDUSTRY
First posted: 2006-01-26
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after two weeks of treatment
Secondary outcomes:
measure: Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after four weeks of treatment.
measure: Assessment of complete relief of heartburn
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Abbottsford
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Guelph
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Lévis
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St-Charles-de-Borromée
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
Study officials:
affiliation: University of Alberta, Division of Gastroenterology, Department of Medicine, Edmonton, Alberta, Canada
name: Alan Thomson, MD, Prof.
role: STUDY_CHAIR
References:
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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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citation: 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. doi: 10.1111/j.1365-2036.2004.02079.x.
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citation: 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. doi: 10.1136/gut.45.2.172.
citation: 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. doi: 10.1046/j.1365-2036.1999.00669.x.
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citation: 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. doi: 10.1211/0022357991772510.