CTRI

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CTRI Number

CTRI/2026/03/106095 [Registered on: 13/03/2026] Trial Registered Prospectively

Last Modified On:

21/04/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

An Interventional Study of Rabeprazole Treatment in 286 Patients with Acid Reflux Disease Not Controlled by Standard PPI treatment

Scientific Title of Study

A randomized, double blind, double dummy, active controlled, parallel-group, multicenter, phase III study to compare the efficacy and safety of rabeprazole sodium 40 mg MR capsule once daily of Dr. Reddys Laboratories Limited with rabeprazole sodium 20 mg Enteric coated Tablet once daily in patients with erosive gastroesophageal reflux disease, refractory to standard PPI therapy

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
DRL-IND-NDA01-RAB/2022 Version 3.0; Dated: 18-OCT-2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Piyush Agarwal
Designation	Head Clinical Development and Clinical Strategy
Affiliation	Dr Reddys Laboratories Ltd
Address	Dr Reddys Laboratories Ltd Integrated Product Development Organization Innovation Plaza Survey nos 42 45 and 46 Bachupally village Medchal Malkajgiri India Dr Reddys Laboratories Ltd Integrated Product Development Organization Innovation Plaza Survey nos 42 45 and 46 Bachupally village Medchal Malkajgiri India Hyderabad TELANGANA 500090 India
Phone	9619097755
Fax	9619097755
Email	piyushagarwal@drreddys.com

Details of Contact Person
Scientific Query

Name	Dr A C Gangaram
Designation	Medical Monitor
Affiliation	Dr Reddys Laboratories Ltd
Address	Dr Reddys Laboratories Ltd Integrated Product Development Organization Innovation Plaza Survey nos 42 45 and 46 Bachupally village Medchal Malkajgiri India Dr Reddys Laboratories Ltd Integrated Product Development Organization Innovation Plaza Survey nos 42 45 and 46 Bachupally village Medchal Malkajgiri India Hyderabad TELANGANA 500090 India
Phone	9740694650
Fax	9740694650
Email	acgangaram@drreddys.com

Details of Contact Person
Public Query

Name	Mr Swarup Wani
Designation	Clinical Operations Manager
Affiliation	Dr Reddys Laboratories Ltd
Address	Dr Reddys Laboratories Ltd Integrated Product Development Organization Innovation Plaza Survey nos 42 45 and 46 Bachupally village Medchal Malkajgiri India Dr Reddys Laboratories Ltd Integrated Product Development Organization Innovation Plaza Survey nos 42 45 and 46 Bachupally village Medchal Malkajgiri India Hyderabad TELANGANA 500090 India
Phone	9154775995
Fax	9154775995
Email	swarupwani@drreddys.com

Source of Monetary or Material Support

Dr. Reddy’s Laboratories Ltd Innovation Plaza, Survey no.’s.: 42, 45, and 46, Bachupally village, Bachupally Mandal, Medchal-Malkajgiri district, Telangana-500 090 Hyderabad, India

Primary Sponsor

Name	Dr. Reddy’s Laboratories Ltd
Address	Innovation Plaza, Survey no.’s.: 42, 45, and 46, Bachupally village, Bachupally Mandal, Medchal-Malkajgiri district, Telangana-500 090 Hyderabad, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 20
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Nachiket Dubale	ACE Hospital and Research Centre Research Department	ACE Hospital and Research Centre Research Department Ground Floor S No 32/2A Erandwane Pune 411004 Maharashtra India Pune MAHARASHTRA	9021133703 drnachi@yahoo.co.in
Dr Aditya Kulkarni	Antarang Hospital	Antarang Hospital New palace road Near Mahaveer College Uday Singh Nagar Raman mala Kolhapur 416003 Kolhapur MAHARASHTRA	8482938975 Aditya.vkulkarni14684@gmail.com
Dr Rakesh Patel	Ashirwad Hospital and Research Centre	Ashirwad Hospital and Research Centre Maratha Section Near Jijamata Udhyan Ulhasnagar 421004 Thane Maharashtra Thane MAHARASHTRA	9834613273 rppatelge@yahoo.com
Dr Ganesh Koppad	Belgavi Institute of Medical Sciences BIMS	Belgavi Institute of Medical Sciences BIMS Dr B R Ambedkar Rd Sadashiv Nagar Belagavi Karnataka 590019 Belgaum KARNATAKA	97396 04197 gkoppad@gmail.com
Dr Pramod Katare	Care Multispeciality Hospital	Kolte Arcade 1 st floor OPD No 03 department of Gastroenterology Pune Nagar Rd Wagholi Pune Maharashtra 412207 Pune MAHARASHTRA	8830793201 drkatareps@gmail.com
Dr Saurabh Kaushik	Gangasheel Advanced Medical Research Institute	Gangasheel Advanced Medical Research Institute C17 Deen Dayal Puram Near OBC Bank Bareilly Bareilly Uttar Pradesh 243001 India Bareilly UTTAR PRADESH	87007 21469 Drsaurabhkaushik@gmail.com
Dr Ashok Mohite	GI One Hospital	GI One Hospital Amrut Sai Solitaire beside Goldie Cinema near Railway station Aurangabad 431005 Maharashtra Aurangabad MAHARASHTRA	75077 48057 armohite26@gmail.com
Dr Anumula Kavitha	Government General Hospital	RoomNo220 2nd floor Department of Gastroenterology GMCANA building Government General Hospital Guntur -522001 Guntur ANDHRA PRADESH	9399977555 jananigastro@ymail.com
Dr Jignesh Patel	HCG Hospitals	HCG Hospitals Mithakhali Ellisbridge Ahmedabad Gujrat 380006 India Ahmadabad GUJARAT	9727735536 drjigs2712@gmail.com
Dr Santosh Hajare	K.L.E.’s Dr. Prabhakar Kore Hospital and Medical Research Center	KLE s Dr Prabhakar Kore Hospital and Medical Research Center Nehru Nagar Belagavi 590010 Karnataka Belgaum KARNATAKA	94481 11913 drsantoshhajare@gmail.com
Dr Sandeep Nijhawan	Mahatma Gandhi Medical college and Hospital	Mahatma Gandhi Medical college and Hospital Riico Institutional Area Sitapura Jaipur Sanganer Rajasthan 302022 India Jaipur RAJASTHAN	98292 72233 sandeepnijhawan16@gmail.com
Dr Kaivan Shah	Navneet Memorial Hospital	Ground Floor OPD Room no 1/2TelExchange Chimanlal Girdharlal Rd Opposite Navrangpura Mithakhali Navrangpura Ahmedabad Ahmadabad GUJARAT	9833622433 drkaivanshah12@gmail.com
Dr Anirban De	Panacea hospital A unit of Aaroha Healthcare Pvt Ltd	Panacea hospital A unit of Aaroha Healthcare Pvt Ltd B 36 44 B4 Near Sanjay Shiksha Niketan Kabir Nagar Durgakund Varanasi 221005 Uttar Pradesh Varanasi UTTAR PRADESH	75488 35016 anirbande14@gmail.com
Dr Sachin Dhande	Sanjeevani Criticare and Research Center Pvt. Ltd.	1 st floor OPD No 01 Department of Gastroenterology Narayan Sankul Near Mahalaxmi Talkies Dindori Road Panchavati Nashik 422003 Nashik MAHARASHTRA	8151994080 ausrinehealthcare2022@gmail.com
Dr Harit Kothari	Santosh Medical college and Hospital	Santosh Medical college and Hospital Ambedkar Rd Near Old Bus Stand Maliwara Nehru Nagar Ghaziabad Uttar Pradesh 201001 India Ghaziabad UTTAR PRADESH	99366 41064 hrt_kothari@yahoo.co.in
Dr Sunil kumar Mahavar	SMS Medical College	SMS Medical College Hospital Department of Medicine Jaipur 302004 Rajasthan India Jaipur RAJASTHAN	94602 59469 dr.sunilmahavar09@gmail.com
Dr Prasad Bhate	Sparsh Speciality Hospital	1 st floor OPD No 02 Department of Gastroenterology Adarsh Nagar Kalewadi Main Road Pimpri Chinchwad Pune Maharashtra 411017 Pune MAHARASHTRA	9970849872 drpbhate@gmail.com
Dr Mahesh Mangulkar	Supe Heart & Diabetis Hospital	Supe Heart and Diabetis Hospital Supe Heart Diabetes Hospital and Research Centre Opp Adharashram Gharpure Ghat Near Rungtha School Ashok Stambha Nashik Maharashtra 422002 India Nashik MAHARASHTRA	9146958116 maheshmangulkar22@gmail.com
Dr Sandeep Prajapati	Swaroop Rani Neharu Hospital	Swaroop Rani Neharu Hospital MLN College George Towm Prayagraj 211002 Uttar Pradesh India Allahabad UTTAR PRADESH	73765 86690 dr.sandeepkpct@gmail.com
Dr Venugopal HG	Victoria Hospital	Victoria Hospital Bangalore Ground Floor Dept Of Surgical Gastroenterology Victoria Hospital Fort K R Road Bangalore 560002 Bangalore KARNATAKA Bangalore KARNATAKA	98455 27042 drvenugopalhg@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 20
Name of Committee	Approval Status
Ashirwad thics Committee	Approved
Aster Adhar Ethics Committee	Approved
Care Multispeciality Hospital Institutional Ethics Committee	Approved
Ethics Committee of BMCRI Bangalore	Approved
Ethics Committee SMS Medical College	Approved
Ikon ethics committee for research on human subjects	Approved
InstitLrtional [,tirics Comn.rittee olGuntur ]!.letlic:rl ColIesr Colernnrent Gcncral I lospitai	Approved
Institutional Ethics Committee (IEC) of MLN Medical College	Approved
Institutional Ethics Committee Belagavi Institute of Medical Sciences	Approved
Institutional Ethics Committee for Sehgal Nursing Home	Approved
Institutional Ethics Committee Gangasheel Advanced Medical Research Institute	Approved
Institutional Ethics Committee HCG Hospitals	Approved
Institutional Ethics Committee of KLE Academy Of Higher Education and Research	Approved
Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital	Approved
Institutional Ethics Committee- ACE Hospital	Approved
Krishna Ethics Committee	Approved
Mumbai Oncocare Centre Institutional Ethics Committee Pune	Approved
Shree Siddhivinayak Hospital Ethics Committee	Approved
Supe Hospital Ethics Committee	Approved
Sushrusha Navneet Memorial Hospital Ethics Committee	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K928\|\|Other specified diseases of the digestive system,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Rabeprazole 20 mg enteric coated	Patient in comparator arm will receive Rabeprazole 20 mg enteric coated tablet and matching placebo of Rabeprazole 40mg MR capsule OD for upto 8 weeks
Intervention	Rabeprazole Sodium MR capsule 40 mg	Patient in test arm will receive rabeprazole 40 mg MR capsules and matching placebo Rabeprazole 20 mg enteric coated tablet OD for upto 8 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1 Males and females aged between 18 and 65 years both inclusive 2 Subject diagnosed with endoscopically confirmed erosive GERD and experiencing GERD symptoms heartburn or regurgitation on more than 4 days per week for at least 4 weeks prior to screening visit. Los Angeles (LA) Classification System for erosive Esophagitis to be used 3 Subjects on once daily Proton Pump Inhibitors for at least 8 weeks prior to screening 4 Subjects without any organic GI tract pathology based on upper GI endoscopy 5 Subjects willing to provide written informed consent and willing to comply with study instructions for its duration 6 Female subjects of child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period OR Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject). OR Postmenopausal for at least 1 year

ExclusionCriteria

Details

1History of hypersensitivity or allergy to any of the study drugs or it components
2.subjects with presence of alarming symptoms for probable malignancy( eg weight loss greater than 5% in the last 60 days persistent vomiting progressive dysphagia orodynophagia

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Double Blind Double Dummy

Primary Outcome

Outcome	TimePoints
To evaluate the efficacy of Rabeprazole 40 mg MR capsule in comparison to Rabeprazole 20 mg Enteric coated tablet in patients with erosive Gastroesophageal Reflux Disease, Symptomatic despite receiving standard once daily PPI for at least 8 weeks prior to randomization	4 weeks , 8 weeks

Secondary Outcome

Outcome	TimePoints
To evaluate the safety and efficacy of Rabeprazole 40 mg MR capsule in comparison to Rabeprazole 20 mg Enteric Coated tablet in patients with erosive Gastroesophageal Reflux Disease, Symptomatic despite receiving standard once daily PPI for at least 8 weeks prior to randomization	8 weeks

Target Sample Size

Total Sample Size="286"
Sample Size from India="286"
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 3

Date of First Enrollment (India)

25/03/2026

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="1"
Months="0"
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

Gastroesophageal reflux disease (GERD), the most common gastrointestinal (GI) disorder, observed by gastroenterologists, surgeons, and primary care physicians. GERD is defined as symptoms or lesions that result from the retrograde flow of gastric contents into the esophagus.1 Proton pump inhibitors (PPIs), after acid activation to sulfonamides, covalently bind to cysteine residues on the luminal surface of H+/K+ ATPase proton pumps in the parietal cells, blocking ion transport andacid secretion Although PPIs are currently the most effective treatment for GERD and its complications.1,3 Patients with continued symptoms despite PPI treatment are considered to have refractory GERD. Up to 30% of GERD patients experience refractory GERD.4 Up to 40% of patients with non-erosive reflux disease (NERD) remain symptomatic on standard therapy, and approximately 10–15% of patients with erosive esophagitis (EE) do not achieve full remission after 8 weeks of treatment.

Multiple factors are likely to explain these treatment failures, in an attempt to improve acid suppression of PPIs, clinicians have given larger single doses or administered the drugs multiple times a day. Both delayed release (DR) & immediate release (IR) PPIs have relatively rapid delivery of drugs in the small intestine for absorption into systemic circulation and equally rapid elimination process through combination of hepatic metabolism & renal excretion