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CTRI Number  CTRI/2025/09/095237 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 20/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How well and how safely two medicines, Vonoprazan and Pantoprazole, help heal stomach acid damage in the food pipe of patients in a North Indian hospital 
Scientific Title of Study   Evaluation of efficacy and safety of Vonoprazan in comparison to Pantoprazole in healing of erosive esophagitis in a tertiary care centre in North India: A pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyoti Khanna 
Designation  Associate Professor 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences 
Address  Department of Pharmacology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical Rd, Rohtak, Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  9813161766  
Fax    
Email  Jyotikhanna.pgims@uhsr.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumit Kumar 
Designation  Junior Resident 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences 
Address  Department of Pharmacology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical Rd, Rohtak, Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  9991326777  
Fax    
Email  drsumit.pharma24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumit Kumar 
Designation  Junior Resident 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences 
Address  Department of Pharmacology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical Rd, Rohtak, Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  9991326777  
Fax    
Email  drsumit.pharma24@gmail.com  
 
Source of Monetary or Material Support  
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak 
 
Primary Sponsor  
Name  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences 
Address  Medical Rd, Rohtak, Haryana 124001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumit Kumar  Pt. B.D. Sharma PGIMS, Rohtak  Room no. 139, 1st floor, Department of Gastroenterology, Medicine Super-speciality, Ch. Ranbir Singh OPD
Rohtak
HARYANA 
9991326777

drsumit.pharma24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K208||Other esophagitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pantoprazole  Pantoprazole 40mg tablet once daily before breakfast for duration of 8 weeks 
Intervention  Vonoprazan  Vonoprazan 20mg tablet give once daily orally for duration of 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  -Patients aged between 18 to 70 years older of either gender.
-Treatment naive patients diagnosed with erosive esophagitis on endoscopy.
-All grades of erosive esophagitis, L.A. Classification, grade A to D.
-Patients or Legally authorised representative willing to provide written informed consent. 
 
ExclusionCriteria 
Details  -Patients with Helicobacter pylori infection with RUT Kit
-Patients with Barret’s esophagus.
-Patients with chronic kidney disease.
-Pregnant or lactating women.
-Signs of gastric malignancy on endoscopy.
-Suffering from acute infections.
-Obese patients with BMI more than 40kg per metre square 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Healing rate of erosive esophagitis   After 8 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Symptom control  Baseline, at 4th & 8th Week 
Need for rescue medication  At 4th & 8th Week 
Compliance/adherence rate assessed via pill count or patient diary and using Brief Medication Questionnaire (BMQ)  At 4th & 8th Week 
Improvement in quality of life using GERD-HRQL questionnaire.  Baseline, at 4th & 8th Week 
Dropouts from the study  At 4th & 8th Week 
Safety profile and adverse events  At 4th & 8th Week (or reported by patient during anytime of the study) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Erosive esophagitis (EE) is a condition characterized by inflammation and visible erosions of the esophageal mucosa, primarily caused by prolonged exposure to gastric acid as seen in gastroesophageal reflux disease (GERD). While occasional reflux is physiologic, persistent reflux overwhelms mucosal defenses and leads to complications such as esophagitis, strictures, and Barrett’s esophagus. In India, EE constitutes a smaller fraction of GERD presentations, with a prevalence of less than 10 percent among symptomatic patients undergoing endoscopy. Despite its relatively lower prevalence, EE is clinically significant due to its potential to cause chronic discomfort, impaired quality of life, and long-term complications like ulceration, bleeding, and even esophageal carcinoma.

Current management of EE relies heavily on proton pump inhibitors (PPIs), which have been the mainstay of acid suppression therapy. However, PPIs have notable limitations: delayed onset of action, incomplete 24-hour acid control, and variable efficacy in rapid metabolizers due to CYP2C19 polymorphisms. These limitations are particularly relevant in the Indian population, which may have different genetic and dietary influences affecting drug response. While PPIs like Pantoprazole are widely used and effective, the variability in therapeutic outcomes has led to the exploration of newer agents. Vonoprazan, a potassium-competitive acid blocker (PCAB), offers a promising alternative with faster onset, potent acid suppression, and minimal influence from CYP2C19 polymorphism. It received FDA approval in year 2022 and CDSCO approval on 8th May 2024. However, there is currently a lack of published clinical studies evaluating its efficacy and safety in the Indian population.

The research question guiding this study is: “Whether Vonoprazan is as effective and safe as Pantoprazole in healing of erosive esophagitis in Indian population?”. The rationale for this study lies in addressing a critical knowledge gap—there is no current Indian data assessing Vonoprazan’s role in EE management, despite its proven potential elsewhere. The hypothesis is that Vonoprazan will demonstrate superior or comparable efficacy with a faster response and better tolerability than Pantoprazole in Indian patients.

The study will involve adult Indian patients diagnosed with EE via upper GI endoscopy, addressing a population for whom region-specific treatment data is lacking. EE will be defined as the presence of mucosal breaks, erosions, or ulceration in the distal esophagus, confirmed by endoscopy and graded using the Los Angeles classification system.

To address this research gap, the proposed study will compare Vonoprazan and Pantoprazole in a randomized, controlled design, evaluating efficacy & safety based on using the GERD-HRQL score and adherence using the Brief Medication Questionnaire(BMQ). The results will provide clinically relevant data to inform future GERD management protocols in the Indian context.

Answering this question could influence future therapeutic guidelines and lead to more personalized, effective management of GERD & its complications in this region based on endoscopic findings, assessment of symptom control, compliance with medication and improvement in quality of life (QoL) of patients with the medication.

 
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