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
- Registration Number
- NCT06953986
- Lead Sponsor
- Asian Institute of Gastroenterology, India
- 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 daily.
Secondary Objectives
* To assess the improvement in reflux symptoms using the GERD-Q score at 8 weeks.
* To evaluate the incidence of adverse events across treatment groups.
- 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, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks.
* Randomization will be stratified by baseline severity of esophagitis (LA grade B vs. C/D).
* The study will be open-label, but the outcome assessors will be blinded. Study Arms
1. Vonaprazan 10 mg once daily
2. Vonaprazan 20 mg once daily
3. Esomeprazole 40 mg once daily
Duration:
* 8 weeks of treatment, followed by endoscopic assessment and symptom evaluation.
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Study Procedures:
Baseline :
* Perform upper GI endoscopy to confirm LA grade B or higher esophagitis.
* Record baseline GERD-Q score.
* Randomize participants into one of the three treatment groups.
* Dispense study medication. Follow-up (Week 4 - Interim Assessment)
* Assess GERD-Q score.
* Monitor adherence and adverse events. End-of-Treatment (Week 8 - Primary Outcome Assessment)
* Repeat upper GI endoscopy to assess mucosal healing.
* Reassess GERD-Q score.
* Collect adverse event data.
* Conclude study participation.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 414
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeks Vonoprazan Vonaprazon 10 mg heals gerd symptoms after 8 weeks To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks Vonoprazan Vonaprazon 20 mg heals gerd symptoms after 8 weeks To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks Esomeprazole 40mg Esomeprazole 40mg heals gerd symptoms after 8 weeks
- Primary Outcome Measures
Name Time Method • Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). 8 weeks healing of ulcers after taking vonaprazon 10mg, 20 mg
Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). 8 weeks healing of ulcers after taking esomeprazole 40mg
- Secondary Outcome Measures
Name Time Method • GERD-Q score improvement at 8 weeks (compared to baseline). 8 weeks symtoms improvement like heartburn, regurgitation which can be calculated with scale 1 (mild symptoms ) to 5 (worse symptoms)
Trial Locations
- Locations (1)
Asian Institute of Gastroenterology /Aig Hospitals
🇮🇳Hyderabad, Telangana, India