GERD
Conditions
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.
Interventions
DRUGVonoprazan
Vonaprazon is potassium competitive acid blockers
DRUGEsomeprazole 40mg
esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • 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
| Measure | Time frame | Description |
|---|---|---|
| • 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) |
Countries
India
Contacts
CONTACTRajesh Goud Mr Maragoni, M.Pharm
CONTACTZaheer Dr Nabi, MD DNB
STUDY_DIRECTORMohan Dr Ramchandani, MD DM
Asian Institute of Gastroenterology
Outcome results
None listed