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CTRI Number  CTRI/2020/09/027980 [Registered on: 23/09/2020] Trial Registered Prospectively
Last Modified On: 04/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A scientific Study to understand the effect of Mebeverine Hydrochloride 135 mg and Chlordiazepoxide 5 mg Tablets in Indian Patient with Management of Irritable Bowel Syndrome 
Scientific Title of Study   A Prospective, Single arm, Multicentric, Post-marketing Observational Study to Evaluate the Effectiveness and Safety of Fixed Dose Combination of Mebeverine Hydrochloride 135 mg and Chlordiazepoxide 5 mg Tablets in the Management of Irritable Bowel Syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MECD5001 Version 1.0 dated 12 Jun 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitesh Pratap 
Designation  Principal Investigator 
Affiliation  Krishna Institute of Medical Sciences Limited 
Address  Room No.1, 1-8-31, Minister Road, Secunderbad-500003

Hyderabad
TELANGANA
500003
India 
Phone  9000150678  
Fax    
Email  pratapnitesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srirupa Das 
Designation  Director Medical Affairs 
Affiliation  Abbott India Ltd 
Address  Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E),Mumbai, MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone    
Fax    
Email  srirupa.das@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Acharya 
Designation  Associate Director – Clinical Development & Pharmacovigilance 
Affiliation  Abbott India Ltd 
Address  Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E),Mumbai, MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  9515161468  
Fax    
Email  shivani.acharya@abbott.com  
 
Source of Monetary or Material Support  
Abbott India Ltd. Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051 
 
Primary Sponsor  
Name  Abbott India Ltd 
Address  Abbott India Ltd. Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Omesh Goyal  Dayanand Medical College & Hospital  Room No.1, Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines, Ludhiana-141001, Punjab
Ludhiana
PUNJAB 		 9914821155

goyalomesh@yahoo.co.in 
Dr Partha Pratim Kalita  Doctor Chamber  Bamundi, Santipur, Guwahati-781103
Sonitpur
ASSAM 		 7399737796

parthapratim.kalita@yahoo.in 
Dr Bhabadev Goswami  Institute of Digestive and liver Disease, Dispur Hospital Pvt Ltd  Room No.1, Institute of Digestive and liver Disease, Dispur Hospital Pvt Ltd, Ganeshguri, Guwahati. Assam-781005
Kamrup
ASSAM 		 9864094739

bhabadev@rediffmail.com 
Dr Nitesh Pratap  Krishna Institute of Medical Sciences Limited  Room No. 1, Krishna Institute of Medical Sciences Limited, 1-8-31, Minister Road, Secunderbad-500003, Telangana, India
Hyderabad
TELANGANA 		 9000150678

pratapnitesh@yahoo.com 
Dr Sumeet Jagtap  Sai Sneh Hospital and Diagnostic center  Room No.1, Sai Sneh Hospital and Diagnostic center, Opp. PMT bus depot, Pune-Satara rd,katraj,pune,Maharashtra-411046
Pune
MAHARASHTRA 		 9822801120

sumeetjagtap0491@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Drug Trial Ethics Committee, Dayanand Medical College & Hospital  Approved 
Institutional Ethics Committee of Sai Sneh Hospital and Diagnostic center  Approved 
KIMS Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K589||Irritable bowel syndrome without diarrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Male and female patients above 18 up to 60 years
Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigator’s discretion, throughout the study. Female of childbearing potential must have a negative pregnancy test and be non-lactating at baseline
Patients who are newly diagnosed with IBS along with anxiety and are recommended the study drug as per investigator discretion
Patient willing to sign Patient Authorization Form (PAF)
 
 
ExclusionCriteria 
Details  Hypersensitivity to the active substances or any of the study drug excipients
Severe respiratory insufficiency, organic brain damage, sleep apnea syndrome, severe, acute or chronic hepatic insufficiency (risk of occurrence of encephalopathy), myasthenia gravis, chronic psychosis, major depressive episodes, phobic or obsessional states, or dementia
Other preexisting GI disorders, patients with history of GI surgery, abnormal upper, and lower GI endoscopy finding
Family history of colon cancer or inflammatory bowel disease
Patients with alarm symptoms (red flag or the symptoms that discriminates lower GI organic diseases from IBS) (Hammer et al 2004); e.g.,
a. Blood in stool
b. Nighttime symptoms that wakes a person
c. Unintentional weight loss
d. Change in typical IBS symptoms will be noted. E.g. new and/or different pain
History of chronic alcoholism or other drug related dependency
History of excessive alcohol intake (women: ≥8 drinks per week; men: ≥15 drinks per week)a
History of addiction to narcotics
Patient who excessively drives or operate hazardous machinery
Any past or present conditions or diseases that investigator considers not appropriate to enter the study
Current use or past history of any medication in last 3 months which might interfere with the action of the study drug
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint of the study is change in mean IBS SSS total score  from baseline to week 8. 
 
Secondary Outcome  
Outcome  TimePoints 
Socio-demographic profile of patients with IBS in terms of  Age, Gender, BMI, Socio economic status (Ghosh and Ghosh 2009), Marital status , Residence, Lifestyle habits, Diet habits,  
Change in mean IBS SSS total score   from baseline to week 4 
Change in mean IBS-SSS score of abdominal pain, number of days of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with QOL   from baseline to Weeks 4 and 8 
Number and percentage of 1IBS SSS responders  at Week 4 and Week 8 
Change in mean IBS 36 score  from baseline to Week 8 
Number and percentage of 2IBS 36 responders   at Week 8  
Change in anxiety total scores on HAM A from baseline to Weeks 4 and 8
1IBS SSS responders: Patients are said to be IBS SSS responders when their overall symptom severity on the
IBS SSS changes to ≥ 50 points (Francis et al 1997).
2IBS 36 responders: Patients are said to be IBS 36 responders when they have the clinically meaningful change of
≥ 10 points on IBS 36 (Passos et al 2009
 		 NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/10/2020 
Date of Study Completion (India) 01/02/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 This is an 8-week prospective, single-arm, multicentric PMOS to evaluate the effectiveness and safety of FDC of Mebeverine hydrochloride 135 mg and Chlordiazepoxide 5 mg in the management of IBS.  Approximately 60 patients with confirmed diagnosis of IBS (available from past medical records), or newly diagnosed patients who have not been taking any medications, in past 3 months for IBS, have anxiety symptoms (HAM-A score [score of at least 18]), and have been prescribed the study drug as a part of the routine practice will be eligible to participate in this study. The study will involve clinical assessments of patients at Screening/Baseline Visit (Day 1, Visit 1), and at or closest to 4 Week (Visit 2), and 8 Week (Visit 3, End of Study [EOS] Visit) after treatment with study drug (Colospa Xâ„¢). Croissance Clinical Research is providing DM support to the study. 
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