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1 Clinical Trial Details (PDF Generation Date :- Fri, 23 Feb :56:59 GMT) CTRI Number Last Modified On 07/02/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/08/ [Registered on: 12/08/2015] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A reserach study to evaluate safety and efficacy of prucalopride tablet in patient having long term complain of constipation A Randomized, Double Blind, Multicentric, Placebo Controlled, Parallel Group Clinical Trial To Evaluate the Efficacy and Safety of Prucalopride in Patients with Chronic Idiopathic 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) Protocol No.: CT/PRUC/CIC/13, Version 3.1, dated 22 Apr 2015 Designation Affiliation Address Protocol Number Details of Principal Investigator Dr Sushilkumar Anand AGM Phone Fax Designation Affiliation Address Torrent Pharmaceuticals Ltd. Torrent Pharmaceutical Ltd Research Centre Village Bhat Dist SushilkumarAnand@torrentpharma.com Details Contact Person (Scientific Query) Dr Sushilkumar Anand AGM Phone Fax Designation Affiliation Address Torrent Pharmaceuticals Ltd. Torrent Pharmaceutical Ltd Research Centre Village Bhat Dist SushilkumarAnand@torrentpharma.com Details Contact Person (Public Query) Dr Sushilkumar Anand AGM Torrent Pharmaceuticals Ltd. Torrent Pharmaceutical Ltd Research Centre Village Bhat Dist page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Torrent Pharamceutical Ltd Research Centre Village Bhat , Dist-, Gujarat, Primary Sponsor Details Torrent Pharamceutical Ltd Address Torrent Pharamceutical Ltd, Research Centre, Village Bhat Dist-, Gujarat, Type of Sponsor NIL List of Countries of Principal Investigator Dr Jagdish Patel Dr Kartikeya Parmar Dr Omesh Goyal Dr Amol Bapaye Dr P Shravankumar Pharmaceutical industry-n Address NIL of Site Site Address Phone/Fax/ Anand Multispeciality Hospital Pvt.Ltd. B.J. Medical College, Civil Hospital Dayanand Medical College and Hospital, Deenanath Mangeshkar Hospital and Research Center Gandhi Medical College & Hospital Anand Multispeciality Hospital Pvt.Ltd, White House, Opp. Rajasthan Hospital, Shahibaug, Ahmedabad Ahmadabad Medicine, B. J. Medical College,Civil Hospital, Asarva Ahmadabad Ahmadabad Gasteroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, Ludhiana PUNJAB Digestive diseases & Endoscopy, 11 Floor, Wing B, Erandwane, Pune , Pune MAHARASHTRA Pune MAHARASHTRA Gandhi Hospital, Musheerabad, Secunderabad drjbpatel@hotmail.com drkartik@gmail.com goyalomesh@yahoo.co.in amolbapaye@gmail.co m shravangastro@gmail.c om page 2 / 8

3 Dr Metlapalli Jagan Mohan Dr Kapil Dev Jamwal DR G K Dhali Dr Sanjiv Haribhakti Dr Palakurthy Murli Krishna Dr Abhijit Chandra Dr Sangitanjan Dutta Government Siddhartha Medical College Insitute of Liver & Biliary Sciences, Institute of Post Graduate Medical Education & Research Kaizen Hospital Institute of Gastroenterology & Research Centre King George Hospital King George s Medical University Marwari Hospital and Research Centre Dr Krishnadas Devadas Medical College Hospital , Telangana Hyderabad Government Siddhartha Medical College, Ring road, Gunadala, Vijaywada Andhra pradesh Krishna D-1 Vasant Kunj, New Delhi , New Delhi DELHI Division of gastroenterology, school of digestive and liver diseases,244- Acharya Jagadish Chandra bose road Kolkata WEST BENGAL Kolkata WEST BENGAL 132 Feet Ring Road, Near Helmet Circle, Memnagar, Ahmedabad , Gujarat, Ahmadabad Super Speciality Block, King George Hospital, Maharanipeta, Vishakh apatnam , Andhra Pradesh Visakhapatnam Surgical New Surgical Block,Ground Floor Shahmina Road, Chowk, Lucknow UTTAR PRADESH Marwari Hospital and Research Centre, S. J. Road, Athgaon, Guwahati, Kamrup ASSAM Medical researchmcggh14@gm ail.com drkapil222@gmail.com gkdhali@yahoo.co.in sharibhakti@gmail.com muralikrishna63@yaho o.com abhijitchandra@hotmail.com sangitdutta@gmail.com page 3 / 8

4 Dr Boddu Prabhakar Dr Indraneel Saha Dr Usha Dutta Dr Shobna Bhatia Dr Naresh Banshal Dr Sarat Panigrahi Osmania General Hospital Peerless Hospital and B. K. Roy Research Center Postgraduate Institute of Medical Education and Research Seth G.S. Medical College and KEM Hospital Sir Ganga Ram Hospital Sparsh Hospitals and Critical care private limited Medical College Hospital, Medical College PO, Thiruvananthapuram, Thiruvananthapuram KERALA Department Of Liver Care Unit, Afzal Gunj, Hyderabad Hyderabad ANDHRA PRADESH Hyderabad Peerless Hospital and B. K. Roy Research Center, 360 Panchasayar,Kolkata , Kolkata WEST BENGAL Dept of Gastroenterology PGIMER sector 12 Chandigarh Chandigarh CHANDIGARH 9th floor, Acharya Donde Marg, Parel, Mumbai: , Maharashtra, Mumbai MAHARASHTRA INSTITUTE OF LIVER GASTROENTEROLOG Y & PANCREATICO BILIARY SCIENCES, Sir Ganga Ram Hospital Marg, Rajinder nagar,new Delhi , New Delhi DELHI Sparsh Hospitals and Critical care private limited, A/407 behind metro tower sahidnagar , Bhubaneswar, odisha, Khordha ORISSA Dr B Ravishankar Sunshine hospital Penderghast Road, Opposite Parsi kdas40@gmail.com bprabhakardr@yahoo.c om isjsid@yahoo.co.in ushadutta@gmail.com sjb@kem.edu drnbansal@ymail.com saratpanigrahi@rediffm ail.com page 4 / 8

5 Details of Ethics Committee Dr Mahesh Naik Vintage Hospital & Medical Research Center Pvt Ltd Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana Hyderabad Gastroe nterology,vintage Hospital & Medical Research Center Pvt Ltd, Caculo Enclave,St. Inez, Panaji, Goa , North Goa GOA com com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Anand Institutional Ethics Committee Drug Trial Ethics Commitee, Dayanand Medical College and hospital, Ludhiana Ethics Committee, Marwari Hospital and Research Centre Ethics committee, Osmania Medical College, Hyderabad Ethics Committee, Sir Ganga Ram Hospital Submittted/Under Committee (IEC) I, Seth Review G S Medical College & KEM Hospital committee, Deenanath Mangeshkar Hospital and research Center, Pune Committee, Gandhi Medical College, Secunderabad committee, King Georges Medical College, Lucknow Committee, Post Graduate Institute of Medical Education and Research, Chandigarh committee, Sparsh Hospital, Bhubaneshwar Approved 06/09/2015 No Approved 12/05/2016 No Approved 04/05/2016 No Approved 15/08/2015 No Approved 04/04/2016 No Submittted/Under Review No Date Specified No Date Specified No No Approved 16/02/2016 No Approved 30/09/2015 No Approved 09/05/2016 No Approved 16/01/2016 No page 5 / 8

6 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Approved 27/02/2016 No Committee, Sunshine Hospital, Secunderabad IPGME&R Research Oversight Committee Kaizen Ethics Committee Peerless Hospital & B K Roy Research Centre Clinical Research Ethics Committee Approved 02/11/2015 No Approved 29/05/2015 No Approved 04/08/2015 No The Committee, B J Medical collge and Civil hospital, Ahmedabad Approved 03/02/2016 No Vintage Institutional Ethics Committee Status Approved 17/12/2015 No Date Approved/Obtained 29/07/2015 Health Type Patients Condition Chronic Idiopathic Constipation Type Details Intervention Prucalopride Succinate 2 mg tablet,once daily, Oral route, Treatment duration: 12 weeks Comparator Agent Age From Age To Gender Details Placebo of Prucalopride succinate Year(s) Year(s) Both Inclusion Criteria Once daily, Oral route, Treatment duration: 12 weeks 1. Male or female patients having age 18 years to 65 years 2. Patient and/or his/her legally accepted representative willing to give written informed consent. 3. Patients with a diagnosis of chronic idiopathic constipation as per modified Rome II criteria. Modified Rome II criteria: Patient reports fewer than three bowel movements (BMs) per week (with each BM occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hr) and reports one or more of the following symptoms for at least 12 weeks, which need not be consecutive, in the 12 months before screening visit or before starting any chronic treatment for constipation. very hard (little balls) and/or hard stools for at least 25% of the bowel movements sensation of incomplete evacuation following at least 25% of the bowel movements straining at least 25% of defecations 4. History of poor results with laxative treatment and diet counseling 5. Patients who report fewer than three complete spontaneous bowel movement (CSBMs) per week during pre-treatment period of 2 weeks after screening (verified at the time of enrolment visit). Exclusion Criteria Exclusion Criteria page 6 / 8

7 Details 1. Patient with history of hypersensitivity to prucalopride or to any of the excipient. 2. Patients with mechanical bowel obstruction, megacolon/megarectum, or diagnosis of pseudo-obstruction (as per colonoscopy). 3. Patients with known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohn s Disease) 4. Patients with history of weight loss 10% of body weight over a period of 6 months. 5. Patients having history of anemia and Hb?12.5 gm/dl for male or Hb?12 gm/dl for female at screening laboratory investigation. 6. Patients on treatment with drugs which are likely to cause constipation e.g tricyclic antidepressants, anticholinergics, narcotic analgesics or calcium channel blockers. 7. Patients with active peptic ulcer. 8. Patient with history of bowel resection or rectal bleeding. 9. Patient with history of Hospitalization for any gastrointestinal or abdominal surgical procedure during the 3 months prior to screening. 10. Patients with TSH 6 µiu/ml or symptoms of hyperthyroidism or hypothyroidism and the same confirmed with laboratory investigation. 11. Patients with clinically significant ECG abnormalities or QTc 450 msec for male or QTc480 msec for female. 12. Clinically significant medical disorder or clinically significant abnormal laboratory finding. 13. History of faecal impaction that required hospitalization or have a history of laxative or enema abuse, ischemia colitis and pelvic floor dysfunction. 14. Patients with liver enzymes (ALT and AST) more than 2.5 times of the normal value and/or bilirubin more than 1.5 times of the normal value. 15. Patient with Serum creatinine more than upper limit of normal value (UNL). 16. Patient with history of malignancy except basal cell carcinoma 17. Pregnant or lactating women. 18. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal, barrier methods or intrauterine device) 19. Patient with history of alcohol or drug abuse in the opinion of the investigator. 20. Participation in any clinical study during last three months Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints Proportion (%) of the patients having an average of at least three or more complete spontaneous bowel movements (CSBMs)/week over the 12 weeks of treatment period It is observed at Week 12 (End of treatment) visit Secondary Outcome Outcome Timepoints Weekly average score of straining Weekly average score of stool consitency Proportion (%) of bowel movements with incomplete evacuation/week Frequency of rescue therapy except bulk It is observed at Week 12 (End of treatment) visit page 7 / 8

8 Powered by TCPDF ( REF/2014/06/ 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 laxatives used per week for constipation Investigator s global assessment of efficacy Total Sample Size=200 Sample Size from =200 25/08/2015 No Date Specified Years=1 Months=0 Days=0 Not Applicable Completed NA Chronic constipation is a highly prevalent, heterogeneous disorder that significantly affects patients lives. Constipation is a common symptom affecting 2 to 27 percent of the population in Western countries. It is more prevalent in women than in men, in nonwhites than in white persons, in children than in adults, and in elderly than in younger adults. Prucalopride is the first compound of a new class of highly selective 5-HT4 agonists with strong enterokinetic activity, with greater selectivity for this receptor than previous prokinetic agents, such as tegaserod and cisapride are. A comprehensive Phase III dataset supports its efficacy in patients with chronic constipation for whom laxatives do not provide adequate relief. page 8 / 8