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SuspendedNCT00282555Updated Mar 19, 2008

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

A Phase 2 interventional study of S-Tenatoprazole-Na (STU-Na) in Esophagitis, Reflux, sponsored by STEBA France. Suspended at 17 sites in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-03-19.

Sponsored by STEBA France · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Esophagitis, Reflux

Keywords

  • Esophagitis, Reflux
  • S-Tenatoprazole-Na
  • Heartburn
  • Esophageal endoscopy
03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 450 is above the median of 66 across 215 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

STEBA France is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
450 participants

Interventions

  • DrugS-Tenatoprazole-Na (STU-Na)
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after four weeks of treatment.

  2. Assessment of complete relief of heartburn

07

Study locations

17 sites
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Abbottsford, British Columbia, Canada
  • Vancouver, British Columbia, Canada
  • Winnipeg, Manitoba, Canada
  • Guelph, Ontario, Canada
  • Hamilton, Ontario, Canada
  • Scarborough, Ontario, Canada
  • Toronto, Ontario, Canada
  • Windsor, Ontario, Canada
  • Lévis, Quebec, Canada
  • Montreal, Quebec, Canada
  • Pointe-Claire, Quebec, Canada
  • Sherbrooke, Quebec, Canada
  • St-Charles-de-Borromée, Quebec, Canada
  • Saskatoon, Saskatchewan, Canada
  • Quebec, Canada
08

References and documents

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. doi: 10.1111/j.1365-2036.2004.02140.x. PubMed 15456460 ↗
  • 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. doi: 10.1159/000200917. PubMed 1397746 ↗
  • 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. PubMed 2142113 ↗
  • 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. PubMed 10364004 ↗
  • 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. doi: 10.1111/j.1365-2036.2004.01893.x. PubMed 15023167 ↗
  • Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000 Mar;22(3):266-80; discussion 265. doi: 10.1016/S0149-2918(00)80032-6. PubMed 10963283 ↗
  • 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. PubMed 16128938 ↗
  • 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. doi: 10.1358/mf.1999.21.3.534827. PubMed 10389120 ↗
  • 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. PubMed 15298633 ↗
  • 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. doi: 10.1159/000028306. PubMed 10450061 ↗
  • 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. PubMed 10403727 ↗
  • 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. PubMed 10594397 ↗
  • 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. doi: 10.1046/j.1365-2036.2000.00788.x. PubMed 10930890 ↗
  • 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. PubMed 10385219 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00282555
Lead sponsor
STEBA France
First posted
Jan 26, 2006
Start date
Feb 2006
Last update
Mar 19, 2008

Study contacts

Alan Thomson, MD, Prof.
study chair · University of Alberta, Division of Gastroenterology, Department of Medicine, Edmonton, Alberta, Canada
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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