CTRI/2025/02/079839 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On:
10/04/2026
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Post approval Safety and Efficacy of Vonoprazan 20 mg Tablets in Indian Patients with Gastroesophageal reflux disease.
Scientific Title of Study
A Phase IV, Post-marketing, Prospective, Multicentric, Single Arm Study to Evaluate
the Safety and Efficacy of Vonoprazan 20mg in Adult Patients with Approved
Indications.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
HCR/IV/VONONERD/08/2024 version 1 & 5-08-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shubhadeep Sinha
Designation
Senior Vice-President
Affiliation
Hetero Labs Limited
Address
Clinical Development and Medical Affairs,
Hetero Drugs Limited,
7-2-A2, Industrial Estates, Sanath Nagar,
Hyderabad, India,
Hyderabad TELANGANA 500018 India
Phone
914023704923
Fax
91-40-23801902
Email
sd.sinha@heterodrugs.com
Details of Contact Person Scientific Query
Name
Dr Sreenivasa Chary
Designation
Senior General Manager
Affiliation
Hetero Labs Limited
Address
Clinical Development and Medical Affairs,
Hetero Drugs Limited,
7-2-A2, Industrial Estates, Sanath Nagar,
Hyderabad, India,
Hyderabad TELANGANA 500018 India
Phone
914023704923
Fax
91-40-23801902
Email
sreenivasa.chary@heterodrugs.com
Details of Contact Person Public Query
Name
Dr Shubhadeep Sinha
Designation
Senior Vice-President
Affiliation
Hetero Labs Limited
Address
Clinical Development and Medical Affairs,
Hetero Drugs Limited,
7-2-A2, Industrial Estates, Sanath Nagar,
Hyderabad, India,
Department of Gastroenterology,
Ground Floor, Room No 7,
Dargamitta, 524004 Nellore ANDHRA PRADESH
9885199996
drsumankonidala666@gmail.com
Dr Kuldeep Singh
Apex Hospital Pvt Ltd
Department of Gastroenterology,
Basement Floor, Clinical Research Department,Room No B01, SP4&6 Malviya Industrial Area, Malviya Nagar,Jaipur,Rajasthan 302017,India Jaipur RAJASTHAN
8132819610
drkuldeepapex123@gmail.com
Dr Ruchir Patel
Dr.M.K.Shah Medical College& Research Centre &Smt SMS Multispeciality Hospital
Department of General Medicine,Ground Floor ,Room No 4, Block B,Near Tapovan Circle, Visat-Gandhinagar, Highway, Chandkheda, Ahmedabad Gujarat-382424 India Ahmadabad GUJARAT
9106804268
drruchirspatel@gmail.com
Dr M Uma Devi
Gandhi Hospital
Department of Gastroenterology
Inpatient Block, 5th Floor,Room No 515
Musheerabad, Secundrabad Telangana 500003,India Hyderabad TELANGANA
9849278271
drmumadevi66@gmail.com
Dr Rahul Bhalgami
Hitech Multispeciality Hospital
Department of Gastroenterology,
Ground Floor, Room No 6, Sector3-D,Plot No 1180,Gh Road ,Nr.Gh-11/2 Bus Stand,
Gandhi nagar, Gujarat -382003,India Gandhinagar GUJARAT
9662052918
rahul_bhalgami@hotmail.com
Dr Manoj Kumar
Jawahar Lal Nehru Medical College
Department of Gastroenterology,
Ground Floor,Room No 101,
Kala Bagh, Ajmer Rajasthan 305001,India Ajmer RAJASTHAN
8118877284
drmanoj.clinical@gmail.com
Dr G Mohan Reddy
Kurnool Medical College/ Govt. General Hospital
Department of Gastroenterology,
Ground Floor, Room No 2,
Budhawara Peta 518002 Kurnool ANDHRA PRADESH
9550563828
drmohangreddy@gmail.com
Dr Subhash Chander
Maharaja Agrasen Superspeciality Hospital
Department of Gastroenterology,
Basement Floor, Clinical Research Department, Room No B11,Central Spine, Agrsen Aspatal Marg, Sector7, VidyadharNagar, Jaipur, Rajasthan 302039,India Jaipur RAJASTHAN
9653433664
dr.subhashchander@outlook.com
Dr Prabhat Ranjan
Mitras Multi-Specialty Hospital
Department of Gastroenterology
Room No 3, Ground Floor Darjiling WEST BENGAL
8384978360
ranjan.prabhat79@gmail.com
Dr Nutan Kumar Agrawal
MLB Medical College
Department of Medicine,
First Floor ,Room No 138
Kanpur Road, Jhansi,
Uttar Pradesh 284128,India Jhansi UTTAR PRADESH
9839789378
dr_nutan_agrawal@yahoo.com
Dr Sunil Kumar Mahavar
SMS Medical College and Attached
Hospital Department of Medicine,
Ground Floor, Room No.1, Dhanvantri OPD, Block SMS Hospital, Jaipur,,Rajasthan 302004,India Jaipur RAJASTHAN
Institutional Ethics Committee, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer,Rajasthan-305001,India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Vonoprazan 20mg
One tablet of Vonoprazan 20 mg should be taken orally once a day in the morning at the same
time after the meal.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Adult male or female patients aged of 18-65 years.
2. Patients willing to give written, signed, and dated informed consent to participate in the study.
3. Patients with Reflux esophagitis (RE)/Gastric Ulcer (GU)/Duodenal Ulcer (DU)/prevention of gastric ulcer or duodenal ulcer during low dose aspirin/administration and NSAIDs administration/adjunct to helicobacter pylori eradication associated with gastric ulcer, duodenal ulcer/ gastric MALT (mucosa-assisted lymphoid tissue) lymphoma, idiopathic thrombocytopenia purpura/ stomach after endoscopic resection of early stage cancer or helicobacter pylori gastritis.
4. Patients (Women of childbearing potential and their partners) must agree to use barrier contraception during the study period
and for 3 months afterward and neither become pregnant or lactate.
ExclusionCriteria
Details
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Treatment emergent clinical & laboratory adverse events (TEAEs) during the
treatment period.
At the end of the Week 4 and week 8
Secondary Outcome
Outcome
TimePoints
1. Change in GERD-FSSG score from baseline to end of 4
weeks.
week 4
2. Change in GERD-FSSG score from baseline to end of 8
weeks.
Week 8
3. Proportion of patients with complete resolution of heartburn
and regurgitation after 4 weeks and 8 weeks.
week 4 & week 8
Target Sample Size
Total Sample Size="200" Sample Size from India="200" 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
Phase 4
Date of First Enrollment (India)
14/02/2025
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="0" Months="8" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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 Phase IV, post-marketing, prospective, multicentric, single-arm study is designed to assess the safety and efficacy of Vonoprazan 20 mg in adult patients diagnosed with gastroesophageal reflux disease (GERD). Participants will be instructed to take one tablet of Vonoprazan 20 mg orally each morning, consistently after their meal. The primary endpoint of the study will focus on the evaluation of treatment-emergent clinical and laboratory adverse events (TEAEs) throughout the treatment duration. Secondary endpoints will include the change in the GERD-FSSG score from baseline to the end of 4 weeks, the change in the GERD-FSSG score from baseline to the end of 8 weeks, and the proportion of patients achieving complete resolution of heartburn and regurgitation at both the 4-week and 8-week marks. The study aims to enroll participants from 8 to 10 sites across India, ensuring their eligibility based on established inclusion and exclusion criteria. After 9 weeks of study period, the results will be analyzed and the data will be presented for product approval.