Actively Recruiting
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
Led by Asian Institute of Gastroenterology, India · Updated on 2026-03-06
414
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the healing rates of reflux esophagitis classified as LA grade B or higher. This study compares three treatments: Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg, taken once daily for 8 weeks. The purpose is to assess which treatment helps heal the esophagus and improves reflux symptoms, as measured by the GERD-Q score, while also monitoring for side effects. Participants will be randomly assigned to one of three groups to receive either Vonaprazan 10 mg, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks. The study is open-label, meaning participants and doctors know the treatment given, but those assessing the healing results are blinded to reduce bias. Treatments focus on acid reduction to promote healing. During the study, participants undergo an upper gastrointestinal endoscopy at the start to confirm esophagitis severity and again after 8 weeks to check healing progress. GERD symptoms are recorded at the beginning, at 4 weeks, and at 8 weeks. Researchers also track medication adherence and any adverse events. The main outcome is the healing of esophagitis at 8 weeks, alongside symptom improvement and safety monitoring throughout the treatment period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Endoscopically confirmed LA grade B, C, or D reflux esophagitis
- GERD symptoms such as heartburn or regurgitation for at least 4 weeks before enrollment
- Willing to provide informed consent and follow study procedures
You will not qualify if you...
- Previous or ongoing treatment with Vonaprazan or Esomeprazole in the last 4 weeks
- Prior esophageal surgery or radiation therapy
- Presence of Barrett's esophagus, esophageal stricture, or cancer
- Pregnant or breastfeeding women
- History of GERD not responding to proton pump inhibitors or severe gastroparesis
- Significant liver or kidney problems (ALT/AST more than 3 times normal, eGFR less than 30 mL/min)
- Use of NSAIDs, steroids, or blood thinners that could affect healing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to confirm eligibility including upper GI endoscopy
Duration - 8 weeks
Participants receive Vonaprazan 10 mg, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks to heal reflux esophagitis.
1 baseline visit, 1 interim assessment visit at Week 4, and 1 end-of-treatment visit at Week 8
Trial Site Locations
Total: 1 location
1
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India, 500082
Actively Recruiting
Research Team
R
Rajesh Goud Mr Maragoni, M.Pharm
Z
Zaheer Dr Nabi, MD DNB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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