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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282555

Enrollment

450

Registered

2006-01-26

Start date

2006-02-28

Completion date

Unknown

Last updated

2008-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagitis, Reflux

Keywords

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

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.

Interventions

DRUGS-Tenatoprazole-Na (STU-Na)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Esophageal endoscopy: assessment of achievement of grade not present in the Los Angeles scale of esophagitis after two weeks of treatment	—

Secondary

Measure	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	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026