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1 Clinical Trial Details (PDF Generation Date :- Thu, 03 Jan :19:24 GMT) CTRI Number Last Modified On 06/01/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/11/ [Registered on: 13/11/2015] - Trial Registered Prospectively Interventional Drug Randomized, Parallel Group, Active Controlled Trial Effectiveness and Safety of Suns Lubiprostone capscule in treatment of Chronic Idiopathic Constipation Efficacy and Safety of SPIL s Lubiprostone capsule, 24 mcg lubiprostone in subjects with Chronic Idiopathic Constipation: A Randomized, Double blind, Parallel group, Active and Placebo Controlled, Clinical Endpoint Bioequivalence Study 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) CLR_10_22 Version 02 Amendment 00, 13 MArch 2013 Name Designation Affiliation Address Phone Fax Name Designation Affiliation Address Phone Fax Name Designation Affiliation Address Protocol Number Details of Principal Investigator Dr Shravanti Bhowmik MD General Manager- Clinical Research Sun Pharma Advanced Research Company Ltd. 17-B Mahal Industrial Estate, Mahakali Caves Road, Andheri-East, Mumbai , India Mumbai India shravanti.bhowmik@sparcmail.com Details Contact Person (Scientific Query) Dr Shravanti Bhowmik MD Associate Vice President- Clinical Research Sun Pharma Advanced Research Company Ltd. 17-B Mahal Industrial Estate, Mahakali Caves Road, Andheri-East, Mumbai , India Mumbai India shravanti.bhowmik@sparcmail.com Details Contact Person (Public Query) Dr Shravanti Bhowmik MD Associate Vice President- Clinical Research Sun Pharma Advanced Research Company Ltd. 17-B Mahal Industrial Estate, Mahakali Caves Road, Andheri-East, Mumbai , India Mumbai page 1 / 10

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax Source of Monetary or Material Support > Sun Pharmaceutical Industries Ltd., 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai , India. Name Address Type of Sponsor Name NIL List of Countries India Name of Principal Investigator Dr Rakesh Patel Dr Murali Krishna P Primary Sponsor Details Sun Pharmaceutical Industries Ltd 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai , India. Pharmaceutical industry-global Address NIL Name of Site Site Address Phone/Fax/ Dhruvi Endoscopy and Liver Clinic Manikya Institute of Gastroenterology and Hepatology 113/115 Hari Om Arcade, Manpada Road, First Floor, Dombivali East, Thane Mumbai MVV Chambers, Near KGH OP Gate Bus Stop, Maharanipeta, Visakhapatnam Visakhapatnam Dr B Ravi Shankar Yashoda Hospital Behind Hari Hara Kala Bhavan, SP Road, Secunderabad Hyderabad Dr B Rameshkumar Dr D Chandra Sekhara Reddy Dr Shrikant Mukewar "Shree Maatre Gastro & Liver Clinic The Legend Commercial Complex, , 136, 1st floor, Barkatpura, Hyderabad Hyderabad Yashoda Hospital, Raj Bhavan Road, Somajiguda, Hyderabad Hyderabad Midas Multispecialty Hospital Pvt Ltd 4th Floor, Midas Height, Central Bazar Road, Ramdaspeth, Nagpur rppatelge@yahoo.com muralikrishna63@yaho o.com b_ravishankar@yahoo. com bhashyakarla_rk@yaho o.co.in deevaguntla@rediffmail.com shrikant_mukewar@ya hoo.com page 2 / 10

3 Dr Suresh Jain Digestive Endoscopy Clinic Nagpur 103, Khopkar Height, Opposite YMCA Club, Quarter Gate Chowk, 383/A, Rasta Peth, Pune " Pune Dr Rajiv Mehta Liver Clinic , Narmada Complex, Near Kadiwala School, Ring Road, Surat , Gujarat " Surat rmgastro@yahoo.com Dr Kaushal Vyas Gujarat Gastro Group 201, Silver Brook A, Opp Doctor House Ellisbridge, Ahmedabad , Gujarat " Ahmadabad DrSathyaprakash Dr Umesh Jalihal Dr Pankaj Desai Department of Gastroenterology MS Ramaiah Medical College and Hospitals Karnataka Gastroenterology Center Gastro Care - Gastro Intestinal Endoscopy Centre, Dr Manish S Bhatnagar Bhatnagar Clinic, Dr Nitin Borse Nasik Digestive Disease & Endoscopy Centre, New BEL Road, MSRIT Post Bangalore Bangalore KARNATAKA 887, Dr. Modi Hospital Road, WCR, Basaveshwaranagar, 2nd Stage, Bangalore " Bangalore KARNATAKA C-150, Shankeshwar Complex, Opp. Raymond Showroom, Sagrampura, Kailashnagar, Surat Surat 2nd Floor, Kamdhenu Complex, Toran Dining Hall Lane, Opp. Sales India, Ashram Road, Ahmedabad Ahmadabad 1st Floor, Rajvee Enclave, Besides Old NMC, New Pandit Colony, Sharanpur Road, Nasik Nashik Dr Chetan Mehta Gastrocare Clinic, Opp. Dr. Bharat Parekh Hospital, Karansinhji Main Road, Rajkot kaushalv27@yahoo.co m satyaprakashbs@gmail. com drumeshj@yahoo.com drp_desai@hotmail.co m bhatnagarclinic@yahoo.com nitinborse@hotmail.co m mehtacn@hotmail.com page 3 / 10

4 Dr Nitin Pai Pai Clinic and Diagnostic Centre Rajkot Abhinav Apartment, / B-1, Shivaji Nagar, Next to Congress House, Pune " Pune Dr Rajesh Dharamsi Dharamsi Hospital, Chandni Chowk, South Shivaji Nagar, Sagli, Sangli Dr Sandeep Nijhawan Dr Javvaji Sateesh Dr Ajit Kumar Dr Subhash Nandwani Dr Govind Verma Dr Ajit Kukreja Department of Gastroenterology - Sawai Man Singh Hospital "Andhra Hospitals, Department of Gastroenterology, Nizam s Institute of Medical Sciences, Department of Gastroenterology, "Gastroenterology & Endoscopy Centre "PACE Hospital, Department of Gastroenterology, Ratandeep Surgical Hospital & Endoscopy Clinic JLN Marg,Jaipur , Rajasthan, India" Jaipur RAJASTHAN rajeshdharamsi@yahoo.co.in drnijhawansandeep@g mail.com C.V.R. Complex, Prakasam Road, Vijayawada , drjavvaji@gmail.com Andhra Pradesh, India " Krishna Punjagutta, Hyderabad, Andhra Pradesh " Hyderabad , Vishwakarma Arcade, Opp. New Civil Hospital, Majura Gate, Ring Road, Surat Gujarat" Surat /11/A/3/1,2,3 Motilal Nehru Nagar SP Road Begumpet Hyderabad Andrapradesh" Hyderabad ajitkrs@yahoo.com subhashnandwani@yah oo.com drgovindverma@gmail. com Nakshtra, IInd FLOOR, Ganesh Gali Maninagar Cross Roads inforsh@gmail.com Ahmedabad Gujarat, India" Ahmadabad Dr Rajvigna Venugopal "Manipal Hospital, Dept. of Gastroenterology, Ground floor, 98, HAL Airport Road, Bangalore , Karnataka, India" Bangalore v2raj@rediffmail.com page 4 / 10

5 Details of Committee Dr Ramesh Roop Rai Dr Sunil Dadhich DrPrashanth Bhandarkar Dr Lalit Shimpi Dr Sheetal Dhadphale Dr S D Wagle Dr Santosh Hajare Dr Shyam sunder sharma RAI Speciality Care Centre, "Kala Endoscopy and Liver Clinic "Shivganga Hospital and Critical Care center Sahyadri Specialty Hospital, Grant Medical Foundation Ruby Hall Clinic, Department of Gastroenterology, King Edwarsd Memorial Hospital (KEM) KARNATAKA H-6 Janpath, Shyam Nagar, Ajmer Road, Sodala, Jaipur rameshroop@gmail.co Rajasthan, India" m Jaipur RAJASTHAN 438, Pal Link Road, Jodhpur RAJASTHAN " Jodhpur RAJASTHAN 24/1 Behind Mount Cmmel School Lokmat square, Dhantoli, Nagpur " Nagpur Deccan Gymkhana, 30C, Erandawane, Karve Road, Pune , Maharashtra, India Pune 6th floor, Cancer building, 40 Sasoon Road, Pune " Pune Dept. of Belgaum , Gastroenterology Karnataka." K.L.E.S Prabhakar Kore Belgaum Hospital & Medical KARNATAKA Research Centre, "Sharma Gastroenterology Centre sunil.dadhich6@gmail.c om gaec@satyam.net.in lalitshimpi@hotmail.co m sheetal_dhadphale@ho tmail.com Dept of Gasteroenterology, TDH Bluiding, 1st Floor, sdwagle@gmail.com Sardar Moodliar Road, Rasta Peth, Pune " Pune House. 107,Guru Jambeshwar Nagar, Lane-3 Queens Road, Vaishali Nagar Jaipur Rajasthan, India. " Jaipur RAJASTHAN drsantoshhajare@hotm ail.com shyamsharma4@rediff mail.com Name of Committee Approval Status Date of Approval Is Independent Committee? Andhra Hospitals-Institutional committee/vijaywada/d r Javvaji Sateesh page 5 / 10

6 APNA Independent Committee/Hydrabad/D r Govind Verma APNA Independent Committee/Hydrabad/D r Srivenu Itha Central India Medical Research Committee/Nagpur/Dr Prashant Bhandarkar Central India Medical Research Committee/Nagpur/Dr Shrikant Mukewar Clinical Forum/Mumbai/Dr Rakesh Patel Yes Approved 25/01/2013 Approved 01/09/2012 Approved 18/09/2012 CLINICOM_Committee for Evaluation of Protocols for Clinical Re seearch/bangalore/dr Umesh Jalihal Approved 05/02/2013 Yes Dharmasi Hospital committee/miraj/dr Rajesh Dharamsi Ethical Board/Bangalore/Dr Satyaprakash Ethical Trial of Health In Community (ETHIC) Committee/Surat/Dr Pankaj Desai Ethical Trial of Health In Community (ETHIC) Committee/Surat/Dr Subhash Nandwani committee for KLE university/belgaum/dr Santosh Hajare committee of Manipal Hospitals/Bangalore/Dr Rajvigna Venugopal Committee of SMS Medical College & Attached hospitals/jaipur/dr Sandip Nijhawan Approved 26/11/2012 Approved 30/11/2012 Committeee of KEM Hospital Research Centre/Pune/Dr S D Wagle Heart First Approved 28/09/2012 page 6 / 10

7 Committe/Surat/Dr Rajiv Mehta Hyderabad Central Committee/Hydr abad/drrameshkumar IMS- Independent Committee - Kala Endoscopy and Liver Clinic/Jaipur/Dr Sunil Dadhich Independent Co Approved 20/11/2012 Yes mmittee/ahmedabad/dr Manish Bhatnagar Institutional Committee/Hydrabad/D r Ravi Shankar Institutional Com mittee/visakhapattnam/ Dr MurliKrishna InstitutionalCom mittee/hydrabad/dr Chandra Sekhara Reddy Mahalasa Independent Committee/Pune/Dr Nitin Pai Mahalasa Independent Committee/Pune/Dr Suresh Jain Approved 28/09/2012 Approved 26/10/2012 Approved 26/11/2012 Nizam s Institute of Medical Sciences-Institutional Thics committee/hydrabad/dr Ajit Kumar Poona Medical Research Foundation/Pune/Dr Sheetal Dhadphale Sahyadri hospitals Ltd. Committee/Pune/Dr Lalit Shimpi Shashvat Independent Committee/Rajkot/Dr chetan Mehta Shatabdi hospital echics committee/nashik/dr Nitin Borse Sukhmani Comm ittee/ahmedabad/dr Ajit Kkureja Yes Yes Yes Approved 11/11/2012 Swapna committ page 7 / 10

8 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria ee/ahmedabad/dr Kaushal Vyas Swasthya Kalyan Committee/Jaipur/Dr Shyam Sunder Sharma Status Date Approved/Obtained 30/08/2013 Health Type Patients Condition Chronic Idiopathic Constipation Type Name Details Intervention Comparator Agent Comparator Agent Age From Age To Gender Details Test (T): Lubiprostone capsule, 24 mcg lubiprostone (Sun Pharmaceuticals Industries Limited, India) Reference (R): Amitiza, lubiprostone capsule, 24 mcg lubiprostone (Sucampo Pharmaceuticals Inc.) Placebo (P): Placebo capsule (Sun Pharmaceuticals Industries Limited, India) Year(s) Year(s) Both Inclusion Criteria 24mcg oral. To take one capsule twice daily orally with food and at least 8 ounces (240 ml) of water for 7 days (a total of 14 capsules). Capsules to be taken at the same time every day. The capsule should be taken once in the morning and once in the evening daily. The capsule should not be taken on an empty stomach. 24 mcg oral. To take one capsule twice daily orally with food and at least 8 ounces (240 ml) of water for 7 days (a total of 14 capsules). Capsules to be taken at the same time every day. The capsule should be taken once in the morning and once in the evening daily. The capsule should not be taken on an empty stomach 24 mcg oral. To take one capsule twice daily orally with food and at least 8 ounces (240 ml) of water for 7 days (a total of 14 capsules). Capsules to be taken at the same time every day. The capsule should be taken once in the morning and once in the evening daily. The capsule should not be taken on an empty stomach 1.Males and non pregnant females aged? 18 years 2.Subjects with a clinical diagnosis of chronic idiopathic constipation defined as, on average, 3.Have 1 or more of the following symptoms related to bowel movements for at least 6 months before the baseline visit and confirmed by daily diary during the 2-week baseline/washout period: 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 page 8 / 10

9 bowel movements straining at defecation at least a quarter of the time 4.Women of child bearing potential practising an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injectable contraceptives] from at least 3 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test. 5.For subjects aged 6.For subjects aged? 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within 1 year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel. 7.Subjects willing not to significantly alter their lifestyle, exercise regimen or diet during the course of the study. 8.Subjects able and willing to give written informed consent. 9.Subjects able to comply with the requirements of the protocol. Exclusion Criteria Details Exclusion Criteria 1.Females who are pregnant, breast feeding, planning a pregnancy, or females of childbearing potential unwilling to use adequate contraception during the course of the study. 2.Subject of any age with evidence of weight loss, anemia, or rectal bleeding AND without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed during the 6 months prior to dosing. 3.Documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/ megarectum, or diagnosis of pseudo-obstruction. 4.Known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohn s Disease) or constipation secondary to a documented cause (e.g., surgery, bowel resection). 5.History of bowel resection. 6.Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing. 7.Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities. 8.Subjects with clinically significant cancer within the last 5 years 9.Subjects with history of any medical/ surgical condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of the study drug. 10.Use within 4 weeks prior to baseline of systemic antibiotic. 11.Use of any prescription and/ or OTC laxatives during the 48 hour period prior to the first dose of study medication. 12.Subjects with a history of hypersensitivity to the study drugs (lubiprostone) or to any of the components (as listed in Section 2.1). 13.Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day). 14.Subjects who have participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration. Method of Generating Random Sequence Method of Concealment Stratified block randomization Pre-numbered or coded identical Containers page 9 / 10

10 Powered by TCPDF ( PDF of Trial Blinding/Masking Double Blind Double Dummy Primary Outcome Outcome Timepoints Number of spontaneous bowel movements (SBM) during week 1 (study days 1-7) During week 1 (study days 1-7) Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Treatment Emergent Adverse Events During week 1 (study days 1-7) Clinically significant change from pre-study to post-study in laboratory parameters, vital signs, physical examination, and 12-lead ECG Total Sample Size=1425 Sample Size from India= /12/2015 Years=1 Months=0 Days=0 t Applicable t Yet Recruiting During week 1 (study days 1-7) This Randomized, Double-blind, Parallel group, Active and Placebo Controlled study is proposed to assess the clinical endpoint bioequivalence of lubiprostone capsule, 24 mcg Lubiprostone of SPIL, India and Amitiza (lubiprostone capsule, 24 mcg lubiprostone) of Sucampo Pharmaceuticals Inc., in male and nonpregnant female subjects with chronic idiopathic constipation page 10 / 10