| CTRI Number |
CTRI/2026/03/105353 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective, Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Observational Study to understand the Tolerability and Efficacy of Vonoprazan in Patients with Reflux Esophagitis. |
|
Scientific Title of Study
|
Vonoprazan In Real world evidence for Tolerability and efficacy in symptomatic
management of reflUx Esophagitis. |
| Trial Acronym |
VIRTUE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshan Rana MBBS MD |
| Designation |
Senior Manager, Medical Affairs |
| Affiliation |
Mankind Pharma Ltd |
| Address |
Mankind Pharma Ltd, 262, Okhla Industrial Estate, Phase-Ill, New Delhi-110020, India.
Mankind Pharma Ltd, Solitaire Corporate Park, Building No 3, Ground Floor, Guru Har Gobind Marg, Andheri East, Mumbai, Maharashtra, 400093
East
DELHI
110020
India |
| Phone |
9766016028 |
| Fax |
|
| Email |
darshan.rana@mankindpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshan Rana MBBS MD |
| Designation |
Senior Manager, Medical Affairs |
| Affiliation |
Mankind Pharma Ltd |
| Address |
Mankind Pharma Ltd, 262, Okhla Industrial Estate, Phase-Ill, New Delhi-110020, India.
Mankind Pharma Ltd, Solitaire Corporate Park, Building No 3, Ground Floor, Guru Har Gobind Marg, Andheri East, Mumbai, Maharashtra, 400093
East
DELHI
110020
India |
| Phone |
9766016028 |
| Fax |
|
| Email |
darshan.rana@mankindpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshan Rana MBBS MD |
| Designation |
Senior Manager, Medical Affairs |
| Affiliation |
Mankind Pharma Ltd |
| Address |
Mankind Pharma Ltd, 262, Okhla Industrial Estate, Phase-Ill, New Delhi-110020, India.
Mankind Pharma Ltd, Solitaire Corporate Park, Building No 3, Ground Floor, Guru Har Gobind Marg, Andheri East, Mumbai, Maharashtra, 400093
East
DELHI
110020
India |
| Phone |
9766016028 |
| Fax |
|
| Email |
darshan.rana@mankindpharma.com |
|
|
Source of Monetary or Material Support
|
| Mankind Pharma Ltd, 262, Okhla Industrial Estate, Phase-Ill, New Delhi-110020 |
|
|
Primary Sponsor
|
| Name |
Mankind Pharma Ltd |
| Address |
262, Okhla Industrial Estate, Phase-Ill, New Delhi-110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 B S Satyaprakash |
Centre for Digestive and Liver Diseases |
Department of Gastroenterology, Gastro division, OPD Room 1, Chat Street, Door No.229, 14th Cross Rd, Vijayanagar, Bengaluru, Karnataka 560040
Bangalore
KARNATAKA |
9845017337
satyaprakashbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PRANAV DIABETES CENTER ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Medical records of adult patients equal or above 18 years of age with symptoms of reflux esophagitis and treated with vonoprazan 20 mg once daily as per local prescribing guidelines will be retrieved and screened for further analysis. |
|
| ExclusionCriteria |
| Details |
Screened records will not be considered for evaluation if patients had esophageal comorbidities, prior gastrointestinal or esophageal surgery, recent use of acid-suppressing therapy, H. pylori eradication within 28 days, significant hepatic dysfunction, inflammatory bowel disease, malignancy, or hypersensitivity to vonoprazan. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness will be evaluated as treatment response based on mean improvement in the FSSG questionnaire score and heart burn resolution |
From baseline till 2 weeks and 4 weeks after treatment initiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physician Global Assessment (PhGA) Scale for treatment response, as well as safety and tolerability evaluated through recorded adverse drug reactions. |
From baseline till 2 weeks and 4 weeks after treatment initiation |
|
|
Target Sample Size
|
Total Sample Size="1800"
Sample Size from India="1800"
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)
|
14/03/2026 |
| 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="0"
Months="0"
Days="15" |
|
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
|
This is a retrospective observational study will conducted in India.
Medical records of adults patients above or equal to 18 years age with reflux esophagitis will be screened, and eligible patients records who are not receiving other
acid-altering medications and are treated with vonoprazan 20 mg once daily for
four weeks will be included in the analysis. Primary outcomes assessed changes in Frequency
Scale for the Symptoms of GERD (FSSG) scores from baseline to Weeks 2 and 4, as well as the proportion of
patients achieving overall heartburn resolution at Week 2 and 4. Secondary outcomes are physician global assessment of treatment response and
safety/tolerability based on recorded adverse drug reactions at week 2 and week 4 |