GERDNCT06955520
Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
A study testing Vonoprazan and Esomeprazole 40mg in people with GERD, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GERD
- What is being tested?
- Vonoprazan and Esomeprazole 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- 30 Apr 2025to 25 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, 500082
ZAHEER DR NABI, MBBS MDDNB, 04023378888 ext. 503, zaheernabi1978@gmail.com
Rajesh Goud Mr Maragoni, M.Pharm MBA, 04023378888 ext. 301, rajeshgoud761@gmail.com
About this study
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:
Read more
- 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.
Read the detailed description
Study Type:
- Randomized, Open-Label, Two-Arm, Non-Inferiority Trial
Randomization and Blinding:
- Randomization: 1:1 ratio between Vonaprazan 20 mg and Esomeprazole 40 mg.
- Stratification: Based on LA grade (B vs. C/D) at baseline.
- Blinding: Open-label study, but outcome assessors will be blinded.
Study Timeline:
- All post-POEM patients receive Esomeprazole 40 mg for 2 months.
- PPI is discontinued for 1 month (to allow reflux esophagitis to develop if persistent GERD exists).
- At 3 months post-POEM, patients with LA grade B or higher esophagitis (on follow-up endoscopy) are randomized to either Vonaprazan 20 mg or Esomeprazole 40 mg for 8 weeks.
- At 8 weeks post-randomization (5 months post-POEM), healing of esophagitis is assessed.
Study Arms:
- Arm A: Vonaprazan 20 mg once daily for 8 weeks
- Arm B: Esomeprazole 40 mg once daily for 8 weeks
Study Procedures:
Baseline Assessment (3 Months Post-POEM, Before Randomization)
- Upper GI Endoscopy: Confirmation of LA grade B or higher reflux esophagitis.
- GERD-Q Score assessment.
- Randomization to Vonaprazan 20 mg or Esomeprazole 40 mg. Follow-Up (Week 4 - Interim Visit)
- GERD-Q Score assessment.
End-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM)
- Upper GI Endoscopy to assess healing of reflux esophagitis.
- GERD-Q Score reassessment.
- Final adverse event reporting.
- Conditions
- GERD
- Being tested
- Vonoprazan, Esomeprazole 40mg
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called per oral endoscopy myotomy
a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.
Esomeprazole 40mgDrug
Also called per oral endoscopy myotomy
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)
| Study group | Role | What they receive |
|---|---|---|
| To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug | Active comparator | healing rate will be checked during endoscopy at 8 weeks Receives: 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 Receives: Drug: Esomeprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis).
This can be find during endoscopy test
Measured: 8 weeks
Secondary outcomes (1)
• Improvement in GERD-Q scores at 8 weeks
GERD questionnaire can be calculated based on heart burn , regurgitation symptom scores which is scaled like 1 is very low symptoms, 5 is worse symptoms (outcome)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start30 Apr 2025
- Primary completion10 Dec 2027 (estimated)
- Study completion25 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Dr Ramchandani, MD DM, Study director, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955520
- Sponsor's protocol ID
- POEMVNP2025
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
- ClinicalTrials.gov ID
- NCT06955520
- Acronym / sponsor ID
- POEMVNP2025
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 25 Dec 2028 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Type:
- Randomized, Open-Label, Two-Arm, Non-Inferiority Trial
Randomization and Blinding:
- Randomization: 1:1 ratio between Vonaprazan 20 mg and Esomeprazole 40 mg.
- Stratification: Based on LA grade (B vs. C/D) at baseline.
- Blinding: Open-label study, but outcome assessors will be blinded.
Study Timeline:
- All post-POEM patients receive Esomeprazole 40 mg for 2 months.
- PPI is discontinued for 1 month (to allow reflux esophagitis to develop if persistent GERD exists).
- At 3 months post-POEM, patients with LA grade B or higher esophagitis (on follow-up endoscopy) are randomized to either Vonaprazan 20 mg or Esomeprazole 40 mg for 8 weeks.
- At 8 weeks post-randomization (5 months post-POEM), healing of esophagitis is assessed.
Study Arms:
- Arm A: Vonaprazan 20 mg once daily for 8 weeks
- Arm B: Esomeprazole 40 mg once daily for 8 weeks
Study Procedures:
Baseline Assessment (3 Months Post-POEM, Before Randomization)
- Upper GI Endoscopy: Confirmation of LA grade B or higher reflux esophagitis.
- GERD-Q Score assessment.
- Randomization to Vonaprazan 20 mg or Esomeprazole 40 mg. Follow-Up (Week 4 - Interim Visit)
- GERD-Q Score assessment.
End-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM)
- Upper GI Endoscopy to assess healing of reflux esophagitis.
- GERD-Q Score reassessment.
- Final adverse event reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug | Active comparator | Drug: Vonoprazanhealing rate will be checked during endoscopy at 8 weeks |
| To see the healing rate of grade B esophagitis | Placebo comparator | Drug: Esomeprazole 40mghealing rate will be checked during endoscopy at 8 weeks in patients receiving esomeprazole 40mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoprazanAlso: per oral endoscopy myotomya potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis. | Drug | To assess the efficacy of vonapraprazon 20mg better than esomeprazole drug |
| Esomeprazole 40mgAlso: per oral endoscopy myotomyIt 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) | Drug | To see the healing rate of grade B esophagitis |
Primary outcome
• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis).
Time frame: 8 weeks
This can be find during endoscopy test
1 secondary outcome
• Improvement in GERD-Q scores at 8 weeks
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for GERD
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohan Dr Ramchandani, MD DM study director
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vonoprazan and Esomeprazole 40mg in people with GERD, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Goud Mr Maragoni, M.Pharm (04023378888 ext. 312, rajeshgoud761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis). (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.