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CTRI Number  CTRI/2024/02/062593 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Eluxadoline in Comparison to Mebeverine for Treatment of Patients With Diarrhoea-Predominant Irritable Bowel Syndrome 
Scientific Title of Study   A Prospective, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of Eluxadoline in Comparison to Mebeverine for Treatment of Patients With Diarrhoea-Predominant Irritable Bowel Syndrome 
Trial Acronym  EXEMPLAR study 
Secondary IDs if Any  
Secondary ID  Identifier 
ICR/23/002, Version 2.0 Dated 31/OCT/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pravin Ghadge 
Designation  AVP and Head_India Clinical Research 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun Pharma Laboratories Limited, Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban) MAHARASHTRA India

Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  02243244324  
Fax    
Email  pravin.ghadge@sunpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shruti Saha 
Designation  Medical Monitor – India Clinical Research  
Affiliation  Sun Pharma Laboratories Ltd 
Address  Sun Pharma Laboratories Ltd, Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai - 400 063, Maharashtra, India.

Mumbai (Suburban)
MAHARASHTRA
400063
India 
Phone  02243244324  
Fax    
Email  Shruti.Saha@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajiv Yadav 
Designation  Senior Manager-India Clinical Research 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai - 400063, Maharashtra, India.

Mumbai (Suburban)
MAHARASHTRA
400063,
India 
Phone  02243244324  
Fax    
Email  Rajiv.Yadav1@sunpharma.com  
 
Source of Monetary or Material Support  
Sun Pharmaceutical Industries Limited (SPIL) Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400 063, Maharashtra, India.  
 
Primary Sponsor  
Name  Sun Pharmaceutical Industries Limited 
Address  Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400 063, Maharashtra, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Sun Pharma Laboratories Limited  Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodaria -390012, Gujarat, India  
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 25  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineet Chaudhari  AIMS  OPD No. 6 , Ground floor, AIMS, P_72, Milap Nagar, MIDC, Dombivli (E), 421203, Mumbai.
Mumbai
MAHARASHTRA 		 7337422597

drvineetchaudhari38@gmail.com 
Dr Ganesh Muniappan  Ashwin Multispeciality Hospital  No. 1, Room no 4, Ground Floor, Alamu Nagar, Sathy Main Road, Coimbatore-641012, Tamil Nadu, India
Coimbatore
TAMIL NADU 		 9600232224

drganeshmuniappan.acr@gmail.com 
Dr Gaurav Singh  Atmaram Childcare & critical care Hospital  Clinical Research Room, Basement Floor, Atmaram Childcare & critical care Hospital, 53Y_128 Y Block Kidwai Nagar, Naubasta, Kanpur, UP-208011
Kanpur Nagar
UTTAR PRADESH 		 9958486790

dr.gauravkrsingh123@gmail.com 
Dr Girish Sonwalkar  Belgavi Institute of Medical Science   Department of General Medicine, Ground Floor, Room no 38, Belgavi Institute of Medical Science Dr Br Ambedkar road sadshivnagar Belgavi 590010
Belgaum
KARNATAKA 		 9448144615

drgirishsonwalkar@gmail.com 
Dr Shashikant Kulgod  BHS Lakeview Hospital  R S No 73/7 CTS No 11888 Opp. Fort Lake Gandhi Nagar Belagavi 590016
Belgaum
KARNATAKA 		 9480188790

skulgod@hotmail.com 
Dr P Shravan Kumar  Gandhi Hospital  Inpatient Block, 5th floor, Department of Gastroenterology, Musheerabad, Secunderabad, Telangana-500003.
Hyderabad
TELANGANA 		 9848011080

shravangastro@gmail.com 
Dr Manoj Gowda  Good Life Hospital  Floor no 1 General Medicine department, Good Life Hospital, No.55,56, Bhoo Smartha Layout, MedahalliKadugodi Road, Bangalore 560049.
Bangalore
KARNATAKA 		 9980985572

drmanojgowda1@gmail.com 
Dr Anumula Kavitha  Government General Hospital  Room No 220, Department of Gastroenterology, GMCANA Building, Guntur-522001-AP
Guntur
ANDHRA PRADESH 		 9399977555

jananigastro@ymail.com 
Dr Mehta Vatsal Kirit Kumar  Health 1 Super Speciality Hospital  5th floor, clinical research department, Near Venitian Villa, Shilaj Circle, S.P Ring Rd, Thalej, Ahmedabad Gujarat 380059.
Ahmadabad
GUJARAT 		 756754644

vatsalmehta6387@gmail.com 
Dr Nath Preetam  KIMS Hospital  2nd Floor, Department of gastroenterology, Main Building, Kusabhadra Campus, Chandaka Industrial Estate, KIIT university, Patia, Bhubaneswar, Odisha-751024
Khordha
ORISSA 		 9438870743

dr.preetamnath@gmail.com 
Dr Santosh Hazare  KLE Dr Prabhakar Kore Hospital and MRC   Department of Gastro, Floor no G+2, Room no 31, KLE Dr Prabhakar Kore Hospital and MRC Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA 		 9448111913

drsantoshhazare@gmail.com 
Dr Agrawal Amitchand Fattechand   LGI Hospital  Ground Floor, Accounts Department, Opposite Yashwant Stadium, Dr N Bhiwapurkar Marg, Dhantoli, Nagpur, 440012.
Nagpur
MAHARASHTRA 		 8805433279

amitagrawal_80@reddifmail.com 
Dr Dhaval Vinay kumar Gupta  Mission Gastro Hospital  603, 6th floor, Clinical Research Room, Golden Icon, Opp. Medilink Hospital, Between Shivranjani-Shyamal Cross Road, 132 Feet Ring Road, Satellite, Ahmedabad-380015.
Ahmadabad
GUJARAT 		 9819277795

drdhavalgupta@gmail.com 
Dr Gaurav Garg  Motilal Nehru Medical College  Room No.101,Ground floor, Motilal Nehru Medical College George town Civil Lines, Prayagraj, Uttarpradesh-211002.
Allahabad
UTTAR PRADESH 		 9528767749

drgauravmln@gmail.com 
Dr Pinaki Roy  Nil Ratan Sircar Medical College and Hospital  Department of Gastroenterology,138 AJC Bose Road Kolkata 700014
Kolkata
WEST BENGAL 		 8777423258

drpinaki1979@gmail.com 
Dr Nikhil Jillawar  Ojas Hospital  Clinical research department, Ground floor, Sr.No.203/1, Bhondve Chowk, sector no.32A, DY Patil College Road, Ravet, Pune-412101.
Pune
MAHARASHTRA 		 9099058141

dr.nikhilojas@gmail.com 
Dr GP Rai  Om surgical centre & Maternity Home  4th floor, Clinical Research Room, Om surgical centre & Maternity Home, SA-17_3, P- 4, Sri krishna Nagar, Paharia ,Ghazipur road, Varanasi- 221007
Varanasi
UTTAR PRADESH 		 9828358410

gprai2992@gmail.com 
Dr Aravind K  PMSSY Super Speciality Hospital  Department of astroenterology, KIMS, Vidyanagar, Hubli, Karnataka-580022
Hassan
KARNATAKA 		 9448241787

drarvindk@yahoo.com 
Dr Anupam Kumar Singh  Post Graduate Institute of Medical Education and Research  Department of Gastroenterology, 3rd Floor, New OPD Block, Post Graduate Institute of Medical Education and Research Sector 12, Chandigarh 160012.
Chandigarh
CHANDIGARH 		 8284822540

anupam.pgi@gmail.com 
Dr Shankar  SilverLine Hospital  Ground floor, C 23, 4th cross (west), Thillai nagar, Trichy -620018
Tiruchirappalli
TAMIL NADU 		 8939465723

drshankar.s123@gmail.com 
Dr Sudhir Maharshi  SMS Medical college and Hospital   Department super speciality building, Near Trauma Centre, Department of Gastroenterology, Room no 218 second floor, 302004, Jaipur Rajasthan, India.
Jaipur
RAJASTHAN 		 8130369247

sudhir.maharshi@gmail.com 
Dr Surendra Kumar  SP Medical College & A G of Hospitals,  Research Room, Near Medicine ICU & Maharaja MRI Department of Medicine, Bikaner-334001 (Rajasthan).
Bikaner
RAJASTHAN 		 9414604192

drsurendrakumar@rediffmail.com 
Dr Lokesh LV  Sparsh Super Specialty Hospital   Department of Gastroenterology 2nd floor OPD, Sparsh Super Specialty Hospital, 146 Infantry Road, Opposite to police commissioners office Bangalore 560001
Bangalore
KARNATAKA 		 9606197707

sparshclinical@gmail.com 
Dr Kaushal Vyas  SVP Hospital  SVP Hospital, C-2 Ground floor , Ellisbridge, Ahmedabad- 380006
Ahmadabad
GUJARAT 		 9825005167

kaushalv27@yahoo.com 
Dr Konatham Rambabu  Visakha Institute of Medical Sciences  Research Room, Department of Medicine, Visakha Institute of Medical Sciences, Visakhapatnam 530040, Andhra Pradesh India.
Visakhapatnam
ANDHRA PRADESH 		 9177747328

drkrambaburesearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 27  
Name of Committee  Approval Status 
Ethics Committee Brij Medical Centre  Approved 
Ethics Committee of Crescent Hospital Heart Centre_LGI Hospital  Approved 
Ethics Committee, SMS Medical college  Approved 
Ethics Committee, SP Medical College  Submittted/Under Review 
Ethics Committee_GMC and GGH  Submittted/Under Review 
Health 1 Super Speciality Hospital Ethics Committee  Approved 
IEC-Om Surgical Center and Maternity Home  Submittted/Under Review 
IEC_Gandhi Hospital  Submittted/Under Review 
Institutional Ethics Committee BIMS  Submittted/Under Review 
Institutional Ethics Committee for Clinical Trial All India Institute of Medical Sciences, Nagpur  Submittted/Under Review 
Institutional Ethics Committee for Human Research  Submittted/Under Review 
Institutional Ethics Committee GMERS medical college  Submittted/Under Review 
Institutional Ethics Committee PGIMER  Submittted/Under Review 
Institutional Ethics Committee Sparsh Hospital  Submittted/Under Review 
Institutional Ethics Committee, AIIMS  Submittted/Under Review 
Institutional Ethics Committee, Ashwin Hospital  Approved 
Institutional Ethics Committee, MLN Medical College  Approved 
Institutional Ethics Committee, NHLIEC  Submittted/Under Review 
Institutional Ethics Committee, NRS Medical College  Submittted/Under Review 
Institutional Ethics Committee_Institute of Medical Sciences Banaras Hindu University  Submittted/Under Review 
Institutional Ethics Committee_KIMS Hospital  Submittted/Under Review 
KIMS Ethics Committee_PMSSY Super Speciality Hospital  Submittted/Under Review 
Medilink Ethics Committee_Mission Gastro Hospital  Submittted/Under Review 
Ojas Multispeciality Hospital Ethics Committee  Submittted/Under Review 
Pranav Diabetes Centre Ethics Committee  Submittted/Under Review 
Suraksha Ethics Committee  Submittted/Under Review 
Visakha Institute of Medical Sciences_IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Eluxadoline tablets 100 mg and matching placebo of Mebeverine  The recommended dosage of Eluxadoline tablets in adults is 100 mg twice daily to be taken with food for 12 weeks. 
Comparator Agent  Mebeverine Prolonged-Release Capsule 200 mg and matching placebo of Eluxadoline  One capsule should be taken orally twice daily 20 minutes before food for 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either gender, age between 18 to 65 years (both inclusive) and willing to provide written informed consent
2. Patient has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhoea as per Rome IV criteria
3. Patient has completed the patient diary on at least 11 of the 14 days during the 2 weeks prior to Randomization
4. Women of childbearing potential must have a negative urine pregnancy test and should be non-lactating before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of the study (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices (IUDs), intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence)
[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Women not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
5. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period]
 
 
ExclusionCriteria 
Details  1. Patient has a diagnosis of other subtypes of IBS [e.g., constipation-predominant IBS, mixed IBS, or unclassified IBS]
2. Prior history of inflammatory or immune-mediated gastrointestinal (GI) disorders
3 Patients with history of other GI disorders
4. Patients with history or current symptoms of colon cancer
5. Patients with any of the following surgical history:
a. Cholecystectomy with ANY history of post cholecystectomy biliary tract pain b. Any abdominal surgery within the 3 months prior to Screening
6. Patients with history of pancreatitis of any etiology or with documented diagnosis of acute pancreatitis
7. Patients with history or current evidence of laxative abuse within 5 years prior to Screening
8. Patients with inadequate hepatic function [(total bilirubin ≥1.5 X ULN) or aspartate transaminase (AST) ≥3 X ULN or alanine transaminase (ALT) ≥3 X ULN] or inadequate renal function [creatinine clearance (CrCL) by Modification of Diet in Renal Disease (MDRD) formula ≤60 ml/min/1.73 m2] at Screening
9. Patients with history of lactose intolerance
10. Patients unable to swallow solid oral dosage forms
11. Patients with documented (microbiological report) lower GI infection within 3 months prior to Screening
12. Patients with uncontrolled hypertension at Screening and Randomization
13. Patients with anaemia at Screening
14. Patients with uncontrolled thyroid disorders
15. Patients with history of stroke, thrombotic event, myocardial infarction, or congestive heart failure (CHF) within 6 months prior to Screening
16. Patients with history of any clinically significant disorder involving hepatic, cardiovascular, renal, pulmonary, metabolic, hematologic, psychiatric condition or any other clinically significant condition requiring treatment which at the investigator’s discretion might interfere with the study
17. Patients with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
18. Patient having hypersensitivity to the study medication or medications of similar chemical classes or to any of its components
19. Patients with history of taking any serotonin (5HT3) antagonists (e.g., ondansetron, granisetron) within 14 days prior to Randomization
20. Patients taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDS) or any other narcotics or any opioid containing agents or antacids containing aluminum/ magnesium or antidiarrhoeal agent or antiemetic agents or antispasmodic agents or bismuth or prokinetic agents
21. Patients taking rifaximin or any other antibiotics (except topical antibiotics)
22. Patients taking antidepressants within 3 months prior to Screening
23. Patients taking analgesics for chronic migraine within 1 month prior to Screening
24. Patients with history of any malignancy within 5 years of Screening
25. Patient with any surgery planned during the study period
26. Patient with history of nicotine and/or alcohol and/or any other substance abuse as per DSM-5 criteria within last 2 years prior to Screening
27. Patient with history of participation in another clinical trial in the past 3 months of Screening
28. Employee of the Sponsor or Investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of Sponsor or the Investigator
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Percentage of composite responders based on improvements from baseline in worst abdominal pain (WAP) and stool consistency score (using BSFS) [Time frame: Week 12]  Up to 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of composite responders based on improvements from baseline in worst abdominal pain and stool consistency score (using BSFS)   up to 8 weeks 
Percentage of responders based on improvements from baseline in BSFS score   Up to 12 weeks 
Change from baseline in BSFS score  Up to 12 weeks. 
Percentage of responders based on improvements from baseline in worst abdominal pain  Up to 12 weeks. 
Change from baseline in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) total score  Up to 12 weeks. 
Change from baseline in Daily Abdominal Discomfort score   Up to 12 weeks. 
Change from baseline in Daily Abdominal Bloating score  Up to 12 weeks. 
Change from baseline in stool frequency per day  Up to 12 weeks. 
Change from baseline in number of bowel incontinence episodes  Up to 12 weeks. 
Change from baseline in number of urgency episodes  Up to 12 weeks. 
Change from baseline in Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL)scale total score  Up to 12 weeks. 
Incidence of TEAEs  Throughout the study period 
 
Target Sample Size   Total Sample Size="356"
Sample Size from India="356" 
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)   21/02/2024 
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="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 study will be a prospective, multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled phase III, comparative study. The study will be conducted at approximately 15 to 20 centers in India, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approval. 
Screening period:
The patient will be screened only after obtaining written informed consent. After obtaining consent, the patients will undergo a screening period of minimum 2 weeks and maximum 3 weeks. At screening visit, study-specific screening (including inclusion and exclusion criteria, medical and medication history, demography, vitals, physical and laboratory examination, 12-Lead ECG) will be performed.
After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will be given study products Eluxadoline 100 mg tablets and matching placebo of Mebeverine OR Mebeverine 200 mg prolonged-release capsules and matching placebo of Eluxadoline orally twice daily. During the study, assessments will be performed as planned in the study. 
 
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