REF/2015/09/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Wed, 07 Feb :42:23 GMT) CTRI Number Last Modified On 26/08/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/10/ [Registered on: 12/10/2015] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group Trial To evaluate efficacy, safety and tolerability of two dose strengths of tacrolimus lipid suspension for injection rectally administered in adult patients with ulcerative colitis A double-blind, randomized, two-arm, parallel, clinical study to evaluate efficacy, safety and tolerability of two dose strengths of tacrolimus lipid suspension for injection rectally administered in adult patients with mild to moderately active left-sided/distal ulcerative colitis including proctosigmoiditis/proctitis refractory to mesalamine treatment 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) , Ver. No- 01, Date- 15 Mar 2014 Protocol Number Designation Affiliation Details of Principal Investigator Ajit Solanki Project Manager Phone Fax Designation Affiliation Lambda Therapeutic Research Ltd Plot No. 32, Near Silver Oak Club, S. G. Highway ajitsolanki@lambda-cro.com Details Contact Person (Scientific Query) Dr Randhirsinh Solanki General Manager Phone Fax Designation Affiliation Lambda Therapeutic Research Ltd Plot No. 32, Near Silver Oak Club, S. G. Highway Randhirsinh@lambda-cro.com Details Contact Person (Public Query) Dr Falgun Vyas Manager Phone Lambda Therapeutic Research Ltd Plot No. 32, Near Silver Oak Club, S. G. Highway page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax > Intas Pharmaceuticals Ltd. Source of Monetary or Material Support Primary Sponsor Details Intas Pharmaceuticals Ltd 2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad , Gujarat, Type of Sponsor Pharmaceutical industry-n Lambda Therapeutic Research Ltd Plot No. 32, Near Silver Oak Club, S. G. Highway, Ahmedabad List of Countries of Principal Investigator Dr Vineet Ahuja Dr Bhabadev Goswami Dr Anumula Kavitha Dr Gopinath R of Site Site Phone/Fax/ All Institute of Medical Sciences Dispur Hospital Pvt. Ltd Institute of Digestive and Liver Disease,Ganeshguri. Kamrup ASSAM Govt General Hospital & Govt Medical Collage Gurushree Hi-Tech Multi speciality Hospital Department Of gastroenterology, Room No: 3093, 3rd floor, vins_ahuja@hotmail.co Teaching block, AIIMS- m New Delhi DELHI Department of Gastroenterology, Room No: 4, Kanna Vari Thota Guntur ANDHRA PRADESH Dept. Of Gestroenterology,# 1558 Opp. Chadra layout Bus stand Vijaynagar Bangalore KARNATAKA Dr Sanjiv Haribhakti Kaizen Hospital Department of Surgical Gastroenterology, 132 ft ring road, Nr Helmet Circle, Memnagar Dr P Murali Krishna King George Hospital Department of Gastroenterology, Super speciality Block, Maharanipeta Visakhapatnam ANDHRA PRADESH bhabadev@rediffmail.c om jananigastro@yamail.co m nrggastro@gmail.com clinicalresearch@kaize nhospital.com muralikrishna63@yaho o.com page 2 / 6

3 Details of Ethics Committee Dr Sathya prakash B S Dr B B Pal Dr Umang Rathi Dr Gopal Krishna Dhali Dr Chetan Mehta Dr Gaurav Kumar Gupta M. S. Ramaiah Medical College and Hospital Peerless Hospitex Hospital and Research centre Ltd. Deparment of Gastroenterology, New BEL road, MSRIT post - satyaprakashbs@gamil com Bangalore KARNATAKA Dept. Of Gestroenterology, Room No.3, 360, Panchasayar Kolkata WEST BENGAL Sanjivani Clinical research Superspeciality Hospital department, 1, Uday park society, Nr. Sunrise park, Vastrapur School of Digestive & Liver Diseases Shree Giriraj Multispeciality Hospital SMS hospital dr_bbpal@yahoo.com drumangrathi@yahoo.c o.in Institute of Post Graduate Medical Education and gkdhali@yahoo.co.in Research, Ronald Ross building, 4th floor, Room No- 17, 244 AJC bose road Kolkata WEST BENGAL Dept. Of Gestroenterology, 150 feet ring road, 27-Navjyot park main road, Amin Marg Cross road Rajkot mehtacn@hotmail.com Department of Gastroenterology,Room No. 1, JLN Marg- kumargauravpgi@gmail com Jaipur RAJASTHAN of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee of SMS medical college & Attached Hospitals,Dr. Gaurav Kumar Gupta Ethics Committee, Dispur Hospitals, Dr Bhabadev Goswami Ethics Committee, Dr. Sathya prakash B. S Committee, Dr. Anumula Kavitha Approved 25/04/2016 No Approved 20/08/2016 No Approved 09/02/2016 No Submittted/Under Review Submittted/Under Committee,Dr. B. B. Pal Review No Date Specified No Date Specified No No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Committee,Dr. Chetan Mehta Committee,Dr. Gopal Krishna Dhali Committee,Dr. Gopinath R Committee,Dr. P Murali Krishna Committee,Dr. Sanjiv Haribhakti Committee,Dr. Vineet Ahuja Sanjivani Hospital Ethics Committee,Dr. Umang Rathi Status Approved 16/04/2015 No Approved 23/05/2015 No Approved 17/07/2015 No Approved 29/05/2015 No Approved 29/05/2015 No Approved 18/03/2016 No Approved 27/01/2016 No Date Approved/Obtained 16/03/2015 Health Type Patients Condition Mild to moderately active left-sided/distal ulcerative colitis including proctosigmoiditis/proctitis refractory to mesalamine treatment Type Details Intervention Tacrolimus 2 mg Dose-2 mg,frequency-60 ml / Once a day,mode of Administration-Rectally administered,duration of treatment-4 weeks Comparator Agent Tacrolimus 4 mg Dose-4 mg,frequency-60 ml / Once a day,mode of Administration-Rectally administered,duration of treatment-4 weeks Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria 1.Documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria with mild to moderate active disease 2.Subjects with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of Rectal bleeding score of 1 or more 4.Mucosal appearance score of 1 point or more at baseline Exclusion Criteria 1.Documented history of proximal or universal ulcerative colitis 2.Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood page 4 / 6

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Sequentially numbered, sealed, opaque envelopes transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis. 3.Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations. 4.Patients stool contains enteric pathogens or Clostridium difficile toxins. Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints To examine the efficacy of a four week treatment of two doses of tacrolimus lipid suspension for injection in patients of distal ulcerative colitis refractory to mesalamine treatment. To end of the study Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 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 1. To evaluate the adverse event (AE) profile of tacrolimus lipid suspension for injection preparations. 2. To estimate the plasma level of tacrolimus following its local administration. Total Sample Size=60 Sample Size from =60 15/10/2015 No Date Specified Years=0 Months=6 Days=0 Not Applicable Open to Recruitment NA To end of the study Lipid-based delivery systems are an accepted, proven and commercially viable strategy to formulate pharmaceuticals, for topical, oral, pulmonary or parenteral delivery. Whether in the form of liposomes, micelles, or emulsions, formulations can be tailored to meet a wide range of product requirements dictated by disease indication, route of administration, and considerations of cost, product stability, toxicity, and efficacy. The proven safety and efficacy of lipid-based carriers make them attractive candidates for the formulation of pharmaceuticals, as well as vaccines, diagnostics and nutraceuticals. The observation that particulates such as long-circulating emulsions and liposomes can passively accumulate at sites of disease or inflammation provides a strong rationale for using lipid-based systems to increase drug bioavailability at the disease site. Lipid-based formulations may also protect active compounds from biological degradation or transformation that in turn can lead to an enhancement of drug potency. Lipid-based delivery systems have been shown to reduce the toxicity and enhance the efficacy of a number of pharmaceuticals. This could also be the case for tacrolimus lipid suspension for injection, wherein it is believed that the viscous lipid based lipid suspension will better adhere to the colon mucous membranes providing longer time for the drug to act. Furthermore the lipid suspension is expected to reach a higher level from the anal verge up to the splenic flexure of colon as compared to aqueous enemas. page 5 / 6

6 Powered by TCPDF ( REF/2015/09/ Given that rectal preparations are not widely available in it is likely that if proven to be efficacious and safe; tacrolimus lipid suspension for injection would be a valuable addition to the treatment options for UC offering symptomatic relief along with longer periods of remission. Hence, we seek to evaluate the efficacy and safety of lipid based tacrolimus lipid suspension for injection in patients with distal UC who fail to achieve symptomatic relief with mesalamine treatment before they are exposed to the risks associated with corticosteroid treatments. page 6 / 6