NCT06953986

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2027

Last Updated

March 6, 2026

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

April 24, 2025

Last Update Submit

March 4, 2026

Conditions

GERD

Outcome Measures

Primary Outcomes (2)

  • • Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).

    healing of ulcers after taking vonaprazon 10mg, 20 mg

    8 weeks

  • Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).

    healing of ulcers after taking esomeprazole 40mg

    8 weeks

Secondary Outcomes (1)

  • • GERD-Q score improvement at 8 weeks (compared to baseline).

    8 weeks

Study Arms (3)

To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeks

OTHER

Vonaprazon 10 mg heals gerd symptoms after 8 weeks

Drug: Vonoprazan

To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks

OTHER

Vonaprazon 20 mg heals gerd symptoms after 8 weeks

Drug: Vonoprazan

To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks

OTHER

Esomeprazole 40mg heals gerd symptoms after 8 weeks

Drug: Esomeprazole 40mg

Interventions

VonoprazanDRUG

Vonaprazon is potassium competitive acid blockers

Also known as: PCAB
To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeksTo determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks
Esomeprazole 40mgDRUG

esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach

Also known as: Proton pump inhibitor
To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineEsomeprazoleProton Pump Inhibitors

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Mohan Dr Ramchandani, MD DM

    Asian Institute of Gastroenterology

    STUDY DIRECTOR

Central Study Contacts

Rajesh Goud Mr Maragoni, M.Pharm

CONTACT

04023378888rajeshgoud761@gmail.com

Zaheer Dr Nabi, MD DNB

CONTACT

04023378888zaheernabi1978@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

December 20, 2025

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

December 12, 2027

Last Updated

March 6, 2026

Record last verified: 2025-04

Locations

IN(1)