Status:
RECRUITING
A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
GERD
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Primary Objective • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks among patients treated with Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg once dail...
Detailed Description
Study Design: * This is a randomized, open-label, parallel-group, non-inferiority trial. Randomization and Blinding * Participants will be randomized in a 1:1:1 ratio to receive Vonaprazan 10 mg, Von...
Eligibility Criteria
Inclusion
- Adults ≥18 years of age.
- Endoscopically confirmed LA grade B, C, or D reflux esophagitis.
- GERD symptoms (heartburn, regurgitation) for at least 4 weeks prior to enrollment.
- Willing to provide informed consent and comply with study procedures.
Exclusion
- Previous or ongoing treatment with Vonaprazan or Esomeprazole in the last 4 weeks.
- Prior esophageal surgery or radiation therapy.
- Barrett's esophagus, esophageal stricture, or malignancy.
- Pregnant or breastfeeding women.
- History of PPI-refractory GERD or severe gastroparesis.
- Significant hepatic or renal impairment (ALT/AST \>3× ULN, eGFR \<30 mL/min).
- Use of NSAIDs, steroids, or anticoagulants affecting healing.
Key Trial Info
Start Date :
June 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2027
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT06953986
Start Date
June 7 2025
End Date
December 12 2027
Last Update
June 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India, 500082