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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Esophagitis, Reflux

Intervention / Treatment
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* Drug: S-Tenatoprazole-Na (STU-Na)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: S-Tenatoprazole-Na (STU-Na)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal endoscopy: assessment of achievement of grade not present in the Los Angeles scale of esophagitis after two weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagitis, Reflux, S-Tenatoprazole-Na, Heartburn, Esophageal endoscopy