NCT00282555

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

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.

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (planned)
• Sponsor: STEBA France · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophagitis, Reflux

Interventions

Type	Name	Description
DRUG	S-Tenatoprazole-Na (STU-Na)

Timeline

• Start date: 2006-02-01
• First posted: 2006-01-26
• Last updated: 2008-03-19

Locations

17 sites across 1 country: Canada