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1 Clinical Trial Details (PDF Generation Date :- Sun, 14 Apr :24:55 GMT) CTRI Number Last Modified On 11/06/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/10/ [Registered on: 27/10/2015] - Trial Registered Prospectively Interventional Drug Randized, Parallel Group, Placebo Controlled Trial Clinical Bioequivalence Study of generic Linaclotiode 290mcg study in IBS-C patients. A RANDOMIZED, DOUBLE MASKED, PARALLEL GROUP, PLACEBO CONTROLLED, MULTICENTRIC STUDY TO EVALUATE THE SAFETY AND EFFICACY OF LINACLOTIDE CAPSULES 290 MCG IN SUBJECTS OF IRRITABLE BOWEL SYNDROME WITH CONSTIPATION Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CR Designation Affiliation Protocol Number Details of Principal Investigator Dr Subhra Lahiri AVP-CR and CDM Phone Fax Designation Affiliation subhra.l@axisclinicals.c Details Contact Person (Scientific Query) Dr Subhra Lahiri AVP-CR and CDM AXIS Clinicals LImited Phone Fax Designation Affiliation subhra.l@axisclinicals.c Details Contact Person (Public Query) Dr Subhra Lahiri AVP-CR and CDM Phone Fax page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > Aurobindo Pharma Limited Type of Sponsor Source of Monetary or Material Support Primary Sponsor Details Aurobindo Pharma Limited APL Research Centre Survey -313 Bachupally Village Qutubullapur Mandal Pharmaceutical industry-n 1-121/1 Miyapur List of Countries of Principal Investigator of Site Site Phone/Fax/ Dr Devendra Singh Apollo Hospitals Seepat Road Lingyadih village Bilaspur Bilaspur CHHATTISGARH Dr Bhabadev Goswami Dispur Hospitals Pvt Ltd Gnaneshwari, Guwahati Assam Kamrup ASSAM Dr Shravan Kumar Gandhi Hospital Department of Gastroenterology Bhoiguda Road Musheerabad Dr Ashwin Porwal Inamdar Multispeciality Hospital S 15 Fatima Nagar Pune MAHARASHTRA Dr GK Dhali IPGMER Kolkata School of Digestive and Liver Disease Institute of Postagraduate Medical Education and Research Kolkata Kolkata WEST BENGAL Dr Sanjay Rajput Kaizen Hospital 132ft ring road Helmet Circle Memnagar Ahmadabad Dr P Muralikrishna King George Hospital Maharanipeta Vishakapatanam Andhra Pradesh Visakhapatnam Dr Abhiji Chandra King Georges Medical University devsvirdi@yahoo.c bhabadev@rediffmail.c shravangastro@gmail.c drashwinporwal@gmail. c gkdhali@yahoo.co.in Clinicalresearch@kaize nhospital.c Muralikrishna63@Yaho o.c Department of Surgical Gastroenterology KGMU Lucknow Chowk abhijitchandra@hotmail page 2 / 6

3 Details of Ethics Cmittee Dr Manish Tandon Dr B PRabhakar Dr Sushil Narang MV hospital and Research Centre Osmania General Hospital SAL Hospital and Medical Institute Lucknow UTTAR PRADESH MIrza Mandi Chowk Lucknow UTTAR PRADESH Department of Gastroenterology Afzalgung Opposite Doordarshan Drive in Road Ahmadabad Dr Hemant Gupta Samvedana Hospital B27 88G Ravindrapuri Varanasi Varanasi UTTAR PRADESH Dr Gaurav Kumar Gupta SMS Hospital JLN Marg Jaipur Jaipur RAJASTHAN Dr Manish Bhatnagar Sterling Hospital Sterling hospital road Memnagar Ahmadabad Dr Pankaj Jain Sterling Hospital Opp I x Race Course Circle West Vadodara Dr Saumin Shah Unique Hospital Opp Kiran Motor Nr canal Civil Hospital Char Rastha Sosyo Circle Lane Off Ring Road Surat.c mtandon2@rediffmail.c bprabhakardr@yahoo.c drsonunarang@gmail.c hemantg26@yahoo.co m kumarggauravpgi@gma il.c drriddimagaur@gmail.c Jain_pass@yahoo.c drsauminshah@gmail.c of Cmittee Approval Status Date of Approval Is Independent Ethics Cmittee? Apollo Hospital Ethics Cmittee Bilaspur Dispur Hospital Ethics Cmittee Ethics Cmittee Inamdar Multispeciality Hospital Pune Gandhi Hospital Ethics Cmittee Cmittee -KGH Cmittee for MV Hospital and Research Centre Approved 14/07/2015 Approved 28/07/2015 Approved 15/06/2015 Date Specified Approved 29/05/2015 Approved 17/05/2015 page 3 / 6

4 Regulatory Clearance Status fr DCGI Health Condition / Problems Studied Intervention / Cparator Agent Inclusion Criteria Cmittee King George Medical College UP Cmittee SAL Hospital IPGME&R Research Oversight Cmittee Kaizen Ethics Cmittee Osmania Medical College Ethics Cmittee Samvedna Hospital Ethics Cmittee Sterling Hospital Ethics Cmittee Sterling Hospital Ethics Cmittee Baroda The Ethics Cmittee-SMS Medical and attached HospitalJaipur Unique Hospital Ethics Cmittee Status Date Specified Approved 02/05/2015 Approved 13/07/2015 Approved 29/05/2015 Approved 02/06/2015 Approved 16/06/2015 Approved 28/04/2015 Date Specified Date Specified Approved 18/05/2015 Date Approved/Obtained 28/09/2015 Health Type Patients Condition Irritable Bowel Syndre - Constipation Type Details Intervention Linaclotide Capsules 290mcg Manufactured by Aurobindo Pharma Limited. To be taken orally one capsules per day 30 minutes before first meal of the day Cparator Agent Linzess Linaclotide 290mcg capsules Distributed by Forest Pharmaceuticals Inc., USA. To be taken orally one capsule 30 minutes before the first meal of the day Cparator Agent Placebo Manufactured by Aurobindo Pharma Limited,. To be taken orally 30 minutes before the first meal of the day. Age Fr Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Male or female aged between 18 to 65 years Ability to provide written informed consent Diagnosed case of IBS according to Re 3 Criteria, who are suffering fr constipation 2 days a week during screening page 4 / 6

5 evaluation. Irritable Bowel Syndre Diagnostic criterion - Re 3 criteria Recurrent abdinal pain or discfort at least 3 days in a month during the last 3 months associated with two or more of the following: Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool Patient has weekly average of worst abdinal pain in past 24 hours score of more than 3 in a 0 to 10 point scale and has less than 3 cplete spontaneous bowel movements CSBM per week. Subjects had no clinically significant findings on physical examination, 12-lead ECG, clinical laboratory tests and urine analysis at the discretion of Principal Investigator. Subjects must have negative test results for HIV 1 and 2 HCV and HBsAg. Subjects agreed to use prescribed method of contraception directed by study team Females of childbearing potential must have a negative pregnancy test. Available for the entire study period and willing to adhere to protocol requirements as evidenced by written informed consent. Exclusion Criteria Details Exclusion Criteria Patient reported loose mushy or watery stools BSFS-Bristol Stool Form Scale score of 6 or 7 in the absence of any laxative, suppository, enema, or prohibited medicine for more than 25 percent of Bowel Movements during the 12 weeks before the Screening Visit Patient currently had both unexplained and clinically significant alarm sympts lower GI bleeding rectal bleeding or heme-positive stool, iron-deficiency anemia or any unexplained anemia, or weight loss and systemic signs of infection or colitis Patient had a structural abnormality of the gastrointestinal GI tract or a disease or history of a condition that could affect GI motility. Patient had a history of potential central nervous system cause of constipation example Parkinson s disease, spinal cord injury, and multiple sclerosis Patient had any of the following diseases or conditions that could be associated with constipation: pseudo-obstruction, colon inertia, megacolon, megarectum, bowel obstruction, descending perineum syndre, solitary rectal ulcer syndre, systemic sclerosis Patient had a diagnosis of familial adenatous polyposis, hereditary non-polyposis colorectal cancer, or any other form of familial colorectal cancer, or inflammatory bowel disease. Patient had a family history of familial adenatous polyposis or hereditary non-polyposis colorectal cancer or other familial form of colorectal cancer Patient having immune system disorders allergic reactions, urticaria, or hives as adverse events or allergic to Linaclotide Patient having Cholelithiasis or other Gallbladder disorders. Patient have done prior abdinal surgery which may cause bowel sympts similar to IBS Patients unable to stop anti-muscarinics, anti-spasmodics, high dose tricyclic antidepressants example above 50 mg per day opiates anti-diarrheal drugs, NSAIDs (occasional over the counter use and topical formulations are allowed), long-term antibiotics, other anti-inflammatory drugs or 5-ASA containing drugs. page 5 / 6

6 Powered by TCPDF ( Method of Generating Rand Sequence Method of Concealment Blinding/Masking Cputer generated randization Centralized Participant, Investigator, Outce Assessor and Date-entry Operator Blinded Primary Outce Outce Timepoints Increase of at least one or more CSBM per week fr Baseline At least 30 percent decrease in weekly average of worst abdinal pain in the past 24 hours score in cparison to Baseline Increase of at least one or more CSBM per week fr Baseline At least 30 percent decrease in weekly average of worst abdinal pain in the past 24 hours score in cparison to Baseline Secondary Outce Outce Timepoints Change in CSBM frequency rate fr Baseline to Week 12. Change in SBM frequency rate fr Baseline to Week 12. Change in stool consistency fr Baseline to Week 12. Change in severity of straining fr Baseline to Week 12 Change in abdinal discfort fr Baseline to Week 12. Change in bloating fr Baseline to Week 12. Change in constipation severity fr Baseline to Week 12 Change in abdinal pain score fr Baseline to Week 12 Nil Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=485 Sample Size fr =485 01/12/2015 Date Specified Years=2 Months=0 Days=0 t Applicable Cpleted Nil Present study is a Clinical Endpoint study. It is a randized, double masked, parallel group, placebo controlled, multicentric study to evaluate the safety and efficacy of Linaclotide capsules 290 mcg in subjects of Irritable bowel syndre with constipation. page 6 / 6