GERDNCT06953986
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
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
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. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteIndia
- Study dates
- 20 Dec 2025to 12 Dec 2027
- 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
- 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.
Who cannot join
- 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.
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, zaheernabi1978@gmail.com
Rajesh Goud Mr Maragoni, M.Pharm MBA, 04023378888 ext. 301, rajeshgoud761@gmail.com
About this study
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
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.
Read the 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
- Vonaprazan 10 mg once daily
- Vonaprazan 20 mg once daily
- 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.
- 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 PCAB
Vonaprazon is potassium competitive acid blockers
Esomeprazole 40mgDrug
Also called Proton pump inhibitor
esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach
| Study group | Role | What they receive |
|---|---|---|
| To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeks | Other | Vonaprazon 10 mg heals gerd symptoms after 8 weeks Receives: Drug: Vonoprazan |
| To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks | Other | Vonaprazon 20 mg heals gerd symptoms after 8 weeks Receives: Drug: Vonoprazan |
| To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks | Other | Esomeprazole 40mg heals gerd symptoms after 8 weeks 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 (defined as resolution of LA grade B, C, or D esophagitis).
healing of ulcers after taking vonaprazon 10mg, 20 mg
Measured: 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
Measured: 8 weeks
Secondary outcomes (1)
• GERD-Q score improvement at 8 weeks (compared to baseline).
symtoms improvement like heartburn, regurgitation which can be calculated with scale 1 (mild symptoms ) to 5 (worse symptoms)
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 posted1 May 2025
- Study start20 Dec 2025
- Primary completion20 Nov 2026 (estimated)
- Study completion12 Dec 2027 (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.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 414 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
- NCT06953986
- Sponsor's protocol ID
- VNP2025
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06953986
- Acronym / sponsor ID
- VNP2025
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 1 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.
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
- Vonaprazan 10 mg once daily
- Vonaprazan 20 mg once daily
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeks | Other | Drug: VonoprazanVonaprazon 10 mg heals gerd symptoms after 8 weeks |
| To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks | Other | Drug: VonoprazanVonaprazon 20 mg heals gerd symptoms after 8 weeks |
| To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks | Other | Drug: Esomeprazole 40mgEsomeprazole 40mg heals gerd symptoms after 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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: PCABVonaprazon is potassium competitive acid blockers | Drug | To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeks, To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeks |
| Esomeprazole 40mgAlso: Proton pump inhibitoresomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach | Drug | To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeks |
Primary outcome
• Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).
Time frame: 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).
Time frame: 8 weeks
healing of ulcers after taking esomeprazole 40mg
1 secondary outcome
• GERD-Q score improvement at 8 weeks (compared to baseline).
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 6 Mar 2026.
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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 4 inclusion and 7 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 6 Mar 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. 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. 410, 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 (defined as resolution of LA grade B, C, or D esophagitis). (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 6 Mar 2026.