NCT06955520

Brief Summary

Peroral Endoscopic Myotomy (POEM) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (GERD), with many patients developing LA grade B or higher esophagitis. Proton pump inhibitors (PPIs) like Esomeprazole are the standard treatment, but Vonaprazan, a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis. Primary Objective:

  • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg. Secondary Objectives
  • To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks.
  • To evaluate the incidence of adverse events in each treatment group.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Apr 2025

Longer than P75 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 Progress28%
Apr 2025Dec 2028

First Submitted

Initial submission to the registry

April 25, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

April 25, 2025

Last Update Submit

April 22, 2026

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

  • • Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis).

    This can be find during endoscopy test

    8 weeks

Secondary Outcomes (1)

  • • Improvement in GERD-Q scores at 8 weeks

    8 weeks

Study Arms (2)

To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug

ACTIVE COMPARATOR

healing rate will be checked during endoscopy at 8 weeks

Drug: Vonoprazan

To see the healing rate of grade B esophagitis

PLACEBO COMPARATOR

healing rate will be checked during endoscopy at 8 weeks in patients receiving esomeprazole 40mg

Drug: Esomeprazole 40mg

Interventions

VonoprazanDRUG

a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.

Also known as: per oral endoscopy myotomy
To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug
Esomeprazole 40mgDRUG

It is a proton pump inhibitor which reduces the excessive acid secretion in the stomach and it heals grade B esophagitis (\>5mm ulcer between two mucosal folds in esophagus)

Also known as: per oral endoscopy myotomy
To see the healing rate of grade B esophagitis

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • History of POEM for achalasia
  • Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 months post-POEM
  • GERD symptoms (heartburn, regurgitation) for ≥4 weeks
  • Willingness to provide informed consent and comply with study procedures

You may not qualify if:

  • History of prior anti-reflux surgery
  • Presence of Barrett's esophagus, esophageal stricture, or malignancy
  • Severe gastroparesis or esophageal motility disorder unrelated to achalasia
  • Pregnancy or breastfeeding
  • Severe hepatic or renal impairment (ALT/AST \>3× ULN, eGFR \<30 mL/min)
  • Regular use of NSAIDs, steroids, or anticoagulants affecting esophageal 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-methylmethanamineEsomeprazole

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-Ring

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 Nabi Dr Mohammed, MD DNB

CONTACT

04023378888zaheernabi1978@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded for this study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 25, 2025

First Posted

May 2, 2025

Study Start

April 30, 2025

Primary Completion (Estimated)

December 10, 2027

Study Completion (Estimated)

December 25, 2028

Last Updated

April 27, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)