CTRI/2025/03/081769 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On:
04/03/2025
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Real world evidence
Study Design
Other
Public Title of Study
An observational study on effect of high dose PPI on severe eGERD
Scientific Title of Study
Management of severe erosive gastroesophageal reflux disease (eGERD)
with high-dose proton pump inhibitors: A real-world observational study
(POWER 3.0)
Trial Acronym
POWER 3.0
Secondary IDs if Any
Secondary ID
Identifier
DRL-IND-GGI-078-RAZO/2024 Version 1.0 Dated 26 Dec 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sagar Katare
Designation
Head - Clinical Research
Affiliation
Dr Reddys Laboratories
Address
8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA, Hyderabad, 500034, India
Hyderabad TELANGANA 500034 India
Phone
9223772427
Fax
Email
sagarkatare@drreddys.com
Details of Contact Person Scientific Query
Name
Dr Sunil Kumar Yadav Yadagiri
Designation
Medical expert
Affiliation
Dr Reddys Laboratories Limited
Address
Dr Reddys Laboratories Limited,8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA, Hyderabad, 500034, India
Hyderabad TELANGANA 500034 India
Phone
9154097829
Fax
Email
sunilkumaryadavy@drreddys.com
Details of Contact Person Public Query
Name
Dr Monjori Mitra
Designation
Research Director
Affiliation
Medclin Research Pvt Ltd
Address
Medclin Research Pvt. Ltd., Acropolis, Unit 10/5, 10th Floor, 1858/1 Rajdanga MainRoad, Kolkata Kolkata WEST BENGAL 700107 India
Kolkata WEST BENGAL 700107 India
Phone
9831075734
Fax
Email
monjori.mitra@medclinsearch.com
Source of Monetary or Material Support
Dr Reddys Laboratories Limited,8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA, Hyderabad, 500034, India
Primary Sponsor
Name
Dr Reddys Laboratories Limited
Address
8 2 337 Road No 3 Banjara Hills Hyderabad TELANGANA, Hyderabad, 500034, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 34
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Piyush Gupta
Advanced Gastro-Liver Care & Endoscopy Center
Department of Gastroenerology, Advanced Gastro-Liver Care & Endoscopy Center, E-1083, Saraswati Vihar Road, Opposite Saral Diagnostics, Pitampura, New Delhi-110034 New Delhi DELHI
9971732369
docpiyushgupta@gmail.com
Dr Ankur Jain
AJ Gastro Liver and Gynae centre – Dwarka
Department of Gastroenterology, AJ Gastro Liver and Gynae centre, 42 - A Doctors lane (DDA FLAT) Behind Sector 6, Main Market, Dwarka, New Delhi - 110075 New Delhi DELHI
7500633371
jainankur88@gmail.com
Dr Sudipta Ghosh
AMRI Hospitals Ltd.
Department of Gastroenterology,JC-16 & 17, No. 3A, Broadway Rd, opp. to Stadium Gate, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 Kolkata WEST BENGAL
9830266072
sudipta121@hotmail.com
Dr Arka Banerjee
Apollo Clinic
Department of Gastroenterology, Apollo Clinic, 26 Diamond Harbour Road Kolkata 700038 Kolkata WEST BENGAL
9433454747
dr.arkobanerjee@gmail.com
Dr Sandip Pal
Aurobindo Eye and Health Care
Department of Gastroenterology, Plot No. 100, East Santoshpur Co-Operrative Society, Barakhola, Mukundapur, Kolkata, West Bengal 700099 Kolkata WEST BENGAL
9434083567
drsandippall@gmail.com
Dr Adarsh CK
BGS Gleneagles Global Hospital, Bengaluru
Department of Gastroenterology, No. 67, 1st Block, Uttarahalli Main Road, Kengeri, Bangalore - 560060 Bangalore KARNATAKA
9844136480
adarshck@gmail.com
Dr Saumil K Shah
Criticare Hospital and Research Centre
Department of Gastroenterology, Criticare Hospital and Research Centre, Plot No. 39, Opp. Juhu Supreme Shopping Centre, Andheri (West), Mumbai 400049 Mumbai MAHARASHTRA
9619321169
samit19sj@gmail.com
Dr Srivenu Itha
Cygnus Institute of Gastroenterology
Department of Gastroenterology, Cygnus Institute of Gastroenterology, Plot No 34 & 35, Nizampet X Road, opp. More Supermarket, Sardar Patel Nagar, Hyderabad, Telangana 500072 Hyderabad TELANGANA
9866755573
srivenu_aiims@yahoo.com
Dr Priyesh Patel
Doctors Planet
Department of Gastroenterology, Doctors Planet, Ground floor, Hamilton building, Dr Priyesh Patel, Doctors Planet Nx, next to Hiranandani hospital, near Indian bank, Hiranandani Estate, Thane, Maharashtra 400607 Thane MAHARASHTRA
85930 06574
drpriyesh128@gmail.com
Dr Dhiren Pipalia
Dr Kamdars Surgical Clinic
Department of Gastroenterology, Dr Kamdars Surgical Clinic, 206, 2nd Floor, Hirachand Desai Rd, Ghatkopar West, Mumbai, Maharashtra 400086 Mumbai MAHARASHTRA
9820134814
dhpipalia@hotmail.com
Dr Ibrahim Hassan Syed
Dr. Ibrahim Hassan Syed Clinic
Department of Gastroenerology, Dr. Ibrahim Hassan Syed Clinic, 4-1-6/2, Mansoor Manzil Eden Garden Rd, near Ramkoti, King Koti, Chowrasta, Hyderabad, Telangana 500001 Hyderabad TELANGANA
9848590290
doctorhassanibrim@yahoo.com
Dr Naresh Kumar Bansal
Institute of Liver Gastroenterology & Pancreatico Biliary Sciences
Institute of Liver Gastroenterology & Pancreatico Biliary Sciences, Sir Ganga Ram Hospital, Sir Ganga Ram Hospital Marg,
Rajinder Nagar, New Delhi, Delhi - 110060
New Delhi DELHI
9310246832
drbansal@ymail.com
Dr Balaji G
Kauvery Hospital - Electronic City
Department of Gastroenterology, No 92, Hubli Survey, 1 B, Hewlett Packard Avenue, Konappana Agrahara, Electronic City, Bengaluru, Karnataka 560100 Bangalore KARNATAKA
8754214878
ballu_hsr@yahoo.co.in
Dr Raj Vigna Venugopal
Kaveri Healthcare
Department of Gastroenterology, Kaveri Healthcare, 259, 3rd cross Rd, Stage 2, Domlur, Bengaluru, Karnataka 560071 Bangalore KARNATAKA
9880755721
V2raj0@gmail.com
Dr Unique Tyagi
Laser stone hospital
Department of Gastroenerology, Laser stone hospital, C1, 10, Sector 15, Pocket 1, Sector 15C, Rohini, New Delhi, Delhi, 110089 New Delhi DELHI
8630471704
ukt2733@gmail.com
Dr Praveen Sharma
Liver & Gastro Care, Delhi
Department of Gastroenerology, Liver & Gastro Care, Delhi G7, Ground Floor, Shop No. 3 & 4, Model Town - IIIrd, New Delhi - 110009 New Delhi DELHI
9810365151
drpraveen_sharma@yahoo.com
Dr Ramesh Garg
Liver and Gastro Clinic, Delhi
Department of Gastroenerology, Liver and Gastro Clinic, Delhi H. No.- D/129, st. no. 13, Opp. Durga mandir, Ashok Nagar Shahdara North, East Delhi- 110093 East DELHI
9811226484
rameshmddm@rediffmail.com
Dr Samit Jain
Liver Wellness Clinic
Department of Gastroenterology, Liver Wellness Clinic, 502, 5th Floor, Sukh Sagar Bldg,NS Patkar Marg Chowpaty, Mumbai 400007 Mumbai MAHARASHTRA
9619321169
samit19sj@gmail.com
Dr Avinash B
M. S. Ramaiah Medical College and Hospitals
Department of Gastroenterology, New BEL Road, M. S. Ramaiah Nagar, MSRIT Post, Bengaluru, Karnataka, India. PIN – 560054 Bangalore KARNATAKA
9731879792
avinashbalekuduru@gmail.com
Dr S M Sivaraj
M.V. Superspeciality Clinic
Department of Gastroenterology, M.V. Superspeciality Clinic, Plot 1C, Mount Poonamallee High Road, Opp. Shanthi Mahal, Kattupakkam, Chennai - 56 Chennai TAMIL NADU
919790700540
dr_sivaraj2002@yahoo.co.in
Dr Shrihari Anikhindi
Medigest Gastro, Liver & Endoscopy Clinic
Department of Gastroenerology, Medigest Gastro, Liver & Endoscopy Clinic, 17 B, B1 Block, Main, Jwala Heri Main Rd, B 1 Block, Paschim Vihar, New Delhi, Delhi- 110063 New Delhi DELHI
9650066604
dr.anikhindi@gmail.com
Dr Ravindra BS
Meenakshi Super Speciality Clinic, Bengaluru
Department of Gastroenterology, Meenakshi arcade, 1st cross, 1st stage arakere mico layout, Bannerghatta main road, Bengaluru 560076 Bangalore KARNATAKA
9916636144
drravindrabs@gmail.com
Dr D Sreenivasa
N.N. Gastroenterology Center
Department of Gastroenterology, RT Nagar Main Rd, next to HDFC BANK II FLOOR, above TITAN SHOW ROOM, Krishnappa Block, RT Nagar, Bengaluru, Karnataka 560032 Bangalore KARNATAKA
9844064700
sreenivasad_gastro@yahoo.co.in
Dr MD Aejaz Habeeb
Origin Hospital, Attapur, Hyderabad
Department of Gastroenerology, Origin Hospital, 2-5-36/CLRD/1, Chintalmet X Roads, Upparapalli, Near Pillar No. 177, PVNR Expressway, Attapur, Hyderabad, Telangana 500048 Hyderabad TELANGANA
9848034860
aejazhabeeb@hotmail.com
Dr Vamshidhar Reddy T
Pioneer Hospital
Department of Gastroenterology, Pioneer Hospital, Plot No. 4 & 5, Hasthinapuram South Nagarjuna Sagar Road, Hyderabad - 500 079 Telangana Hyderabad TELANGANA
9866432457
vamshidhartandra@yahoo.com
Dr Sabyasachi Pattanaik
Saavi Diagnostic Centre
Department of Gastroenterology, Saavi Diagnostic Centre, 8B, Gangadhar Banerjee Ln, Khidirpur, Kolkata, West Bengal 700023 Kolkata WEST BENGAL
9831069879
drspattnaik@yahoo.co.in
Dr Shri Ram Agrawal
Samadhan Clinic
Department of Gastroenterology, Samadhan Clinic, Flat No. 25, Sector 13, Pocket 1, Phase 2, Netaji Subhash Apartments, DDA Flats (Near Nsit Police Check Post), Dwarka, New Delhi 110 045 New Delhi DELHI
9911087347
shriramagr@yahoomail.com
Dr Selvarangan Selvakumar
Selvarangam Hospital
Department of Gastroenterology, Selvarangam Hospital, Chindamani, C-54, 1st Main Rd, Anna Nagar, Chennai, Tamil Nadu 600102 Chennai TAMIL NADU
9841074656
selvagastrochennai@gmail.com
Dr Venkatesan Mahadevan
Sen Hospital
Department of Gastroenterology, Sen Hospital, New No. 51, old, 18, Bunder Garden St, opp. Lourdes Girls Higher Secondary School, Perambur, Chennai, Tamil Nadu 600011 Chennai TAMIL NADU
9841259932
drvenkatesh@yahoo.com
Dr Ravindra Surude
Shree Gastroenterology & Endoscopy Clinic
Department of Gastroenterology, Shree Gastroenterology & Endoscopy Clinic, Shop no.1& 2, D wing, Mandapeshwar Kripa CHS Ltd. SVP Road, Opp St Francis School, Borivali West. Mumbai, Maharashtra, 400103 Mumbai MAHARASHTRA
9819103874
dr.surude@gmail.com
Dr Praveen Mathew
Trinity Gastroenterology And Liver Clinic
Department of Gastroenterology,Trinity Gastroenterology And Liver Clinic, 410, 5th main, 2nd block, HRBR layout, Kalyan Nagar, Bangalore -560043 Bangalore KARNATAKA
9620880555
drpraveenmathew@yahoo.com
Dr Venugopal Reddy KV
Veda Gastro Liver Clinic
Department of Gastroenterology,Veda Gastro Liver Clinic, Pochamma Temple Lane, Lane opposite to McDonlds, Hanuman Nagar, Chaitanyapuri, Dilsukhnagar, Hyderabad, Telangana 500060 Hyderabad TELANGANA
Vishwa Sriman Gastroenterology, Liver Clinic & Endoscopy Center
Department of Gastroenterology, Vishwa Sriman Gastroenterology, Liver Clinic & Endoscopy Center, 67, Vijayapuri Colony, Near Bharath Petrol Pump, Hyderabad, Telangana 500062 Hyderabad TELANGANA
9912384585
grsrinivasrao@gmail.com
Details of Ethics Committee
No of Ethics Committees= 34
Name of Committee
Approval Status
ACE Independent Ethics Committee (Unit of Pranav Diabetes Center)
Approved
ACE Independent Ethics Committee (Unit of Pranav Diabetes Center)
Approved
ACE Independent Ethics Committee (Unit of Pranav Diabetes Center)
Approved
ACE Independent Ethics Committee (Unit of Pranav Diabetes Center)
Approved
ACE Independent Ethics Committee (Unit of Pranav Diabetes Center)
Approved
ACE Independent Ethics Committee (Unit of Pranav Diabetes Center)
Approved
ACE Independent Ethics Committee (Unit of Pranav Diabetes Center)
Approved
Good Society for Ethical Research
Submittted/Under Review
Good Society for Ethical Research
Submittted/Under Review
Good Society for Ethical Research
Submittted/Under Review
Good Society for Ethical Research
Submittted/Under Review
Good Society for Ethical Research
Submittted/Under Review
Good Society for Ethical Research
Submittted/Under Review
Good Society for Ethical Research
Submittted/Under Review
Good Society for Ethical Research
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
Indira IVF Hospital Ethics Committee
Submittted/Under Review
RIPON Independent Ethics Committee
Submittted/Under Review
RIPON Independent Ethics Committee
Submittted/Under Review
RIPON Independent Ethics Committee
Submittted/Under Review
S2J Independent Ethics Committee Holistic Health Care and Research Centre
Submittted/Under Review
S2J Independent Ethics Committee Holistic Health Care and Research Centre
Submittted/Under Review
S2J Independent Ethics Committee Holistic Health Care and Research Centre
Submittted/Under Review
S2J Independent Ethics Committee Holistic Health Care and Research Centre
Submittted/Under Review
S2J Independent Ethics Committee Holistic Health Care and Research Centre
Submittted/Under Review
S2J Independent Ethics Committee Holistic Health Care and Research Centre
Submittted/Under Review
S2J Independent Ethics Committee Holistic Health Care and Research Centre
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Comparator Agent
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male or female greater than equal to 18 years
2. Patients diagnosed with severe erosive GERD by treating physician
3. Patients who were on regular dose of PPI (Rabeprazole 20mg, Pantoprazole 40mg, Omeprazole 20mg/Esomeprazole 40mg) as initial therapy for the last 4 - 8 weeks and with incomplete symptomatic relief
OR
Patients who will be commenced on high dose of PPI (Rabeprazole 40mg, Pantoprazole 80mg, Omeprazole 40mg/Esomeprazole 80mg) as initial therapy
4. Willingness to provide written informed consent
ExclusionCriteria
Details
1. Patients with complications associated with GERD (esophageal stricture, Barretts esophagus, esophagitis and asthma) organic causes
2. Patients with known history of surgical management of GERD
3. Patients with known history of high-dose PPI usage
4. Refusal or inability to comply with the requirements of the protocol for any reason, including answering questionnaires
5. Any other condition(s) that would make the patient, in the opinion of the Investigator, unsuitable for the study
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. Proportion of subjects with severe erosive GERD based on severity of diurnal symptoms heartburn, regurgitation, epigastric distress, and dysphagia graded as follows at baseline, 4 week, and 8 week-
Absent, score 0
Mild, score 1, awareness of symptom, but easily tolerated
Moderate score 2, discomfort sufficient enough to cause interference with normal activities, including sleep
Severe, score 3, incapacitating, with inability to perform normal activities, including sleep
4 week, and 8 week
Secondary Outcome
Outcome
TimePoints
Primary Outcome Continued
3. Proportion of subjects with severe erosive GERD showing improvement in the severity of diurnal symptoms heartburn, regurgitation, epigastric distress, & dysphagia, graded as above, at
4 plus & minus 1 weeks & 8 plus & minus 1 weeks
4. Proportion of subjects with severe erosive GERD showing
improvement in severity of nocturnal symptoms heartburn,
regurgitation, epigastric distress, & dysphagia, graded as above, at
4 plus & minus 1 weeks & 8 plus & minus 1 weeks
5. Change in mean total QOLRAD-RI score from baseline to 4 plus & minus 1 weeks & 8 plus & minus 1 weeks
6. Change in QOLRAD-RI mean domain scores from baseline to 4 plus & minus 1 weeks & 8 plus & minus 1 weeks
4 plus & minus 1 weeks, & 8 plus & minus 1 weeks
Secondary Outcome
1. Demographic profile of enrolled subjects with severe erosive GERD
2. Clinical presentation of severe erosive GERD in enrolled subjects
3. Proportion of subjects with severe erosive GERD experiencing adverse events AEs from baseline to 4 plus & minus 1 weeks & 8 plus & minus 1 weeks
4. Patient satisfaction at 4 plus & minus 1 weeks & 8 plus & minus 1 weeks, graded on a 5-point Likert scale Strongly satisfied=5, Satisfied=4, Not sure=3, Dissatisfied=2, Strongly dissatisfied=1
5. Treatment compliance at 4 plus & minus 1 weeks & 8 plus & minus 1 weeks, graded on a 5-
point scale Never = 5, Rarely = 4, Sometimes = 3, Often = 2, Very often = 1
4 plus & minus 1 weeks, & 8 plus & minus 1 weeks
Exploratory Endpoint:
Change in endoscopic findings from baseline to 4 plus & minus 1 weeks & 8 plus & minus 1 weeks based on available data
4 plus & minus 1 weeks, & 8 plus & minus 1 weeks
Primary outcome continued
2. Proportion of subjects with severe erosive GERD based on severity of nocturnal symptoms heartburn, regurgitation, epigastric distress, & dysphagia graded as above at baseline, 4 plus & minus 1 week, & 8 plus & minus 1 week
4 plus & minus 1 weeks, & 8 plus & minus 1 weeks
Target Sample Size
Total Sample Size="500" Sample Size from India="500" 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)
17/03/2025
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="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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 prospective, observational study will enrol patients clinically diagnosed with severe erosive GERD and satisfying all eligibility criteria. Demographic details (age, gender, height, and weight), information on lifestyle (meal, sleep, smoking, drinking, stress, exercise, etc.), comorbid medical conditions, concomitant medications, and details on GERD and PPI consumption will be collected at baseline. Patients will treated with high dose PPI as per physician’s discretion and the will be monitored to evaluate protocol-defined study outcomes. The patients will be divided into three cohorts based on the prescribed PPIs for analysis purpose.
The severity of symptoms (heartburn, regurgitation, epigastric distress, and dysphagia) will be assessed using a Likert scale. Quality of life will be assessed based on QOLRAD-RI. Data on treatment compliance and
satisfaction will also be collected from patients. Safety will be assessed based on the incidence rate of AEs. Data will be accrued at 4±1 weeks
and 8±1 weeks. Endoscopy results, if available, will be retrieved and analyzed.