| 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
|
|
|
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
|
|
|
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. |