NCT06953986 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
| NCT ID | NCT06953986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | GERD |
| Study Type | INTERVENTIONAL |
| Enrollment | 414 participants |
| Start Date | 2025-12-20 |
| Primary Completion | 2026-11-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 414 participants in total. It began in 2025-12-20 with a primary completion date of 2026-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Mohan Dr Ramchandani, MD DM
STUDY DIRECTOR
Asian Institute of Gastroenterology, India
Frequently Asked Questions
Who can join the NCT06953986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying GERD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06953986 currently recruiting?
Yes, NCT06953986 is actively recruiting participants. Contact the research team at rajeshgoud761@gmail.com for enrollment information.
Where is the NCT06953986 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT06953986 clinical trial?
NCT06953986 is sponsored by Asian Institute of Gastroenterology, India. The principal investigator is Mohan Dr Ramchandani, MD DM at Asian Institute of Gastroenterology, India. The trial plans to enroll 414 participants.