Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GERD
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

I

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.

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.

Primary outcomes:
measure: • Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).
timeFrame: 8 weeks
measure: Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).
timeFrame: 8 weeks
Secondary outcomes:
measure: • GERD-Q score improvement at 8 weeks (compared to baseline).
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology /Aig Hospitals
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Mohan Dr Ramchandani, MD DM
role: STUDY_DIRECTOR
References: