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1 Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar :05:28 GMT) CTRI Number CTRI/2009/091/ [Registered on: 08/10/2009] - Last Modified On 14/08/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial A clinical trial to study the safety and effectiveness of the drug in patients with Ulcerative colitis. Efficacy and Safety of new oral Budesonide-MMX 6 mg and 9 mg extended release tablet formulations in patients with mild or moderate, active Ulcerative Colitis. A multicenter, randomized, double-blind, double dummy comparative study versus Placebo, with an additional reference arm evaluating Asacol 2400 mg. 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) CB-01-02/01 NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Dr Arun Bhatt President Clininvent research pvt. ltd. Phone Fax Designation Affiliation A-103, Everest Chambers Marol Naka, Andheri (E) arunbhatt@clininvent.com Details Contact Person (Scientific Query) Dr Arun Bhatt President Clininvent Research Pvt. Ltd. Phone Fax Designation Affiliation A-103, Everest Chambers Marol Naka, Andheri (E) arunbhatt@clininvent.com Details Contact Person (Public Query) Dr Arun Bhatt President Clininvent Research Pvt. Ltd. Phone A-103, Everest Chambers Marol Naka, Andheri (E) page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > COSMO Technologies Ltd Amiens Street Dublin 1 Ireland > Santarus, Inc Valley Centre Drive, Suite 400 San Diego, CA Type of Sponsor Santarus Inc List of Countries Canada Mexico United States of America of Principal Investigator Dr Nageshwar Reddy Primary Sponsor Details COSMO Technologies Ltd Amiens StreetDublin 1Ireland Pharmaceutical industry-global 3721 Valley Centre Drive, Suite 400San Diego, CA of Site Site Phone/Fax/ Asian Institute of G-3-661,Somajiguda Hyderabad Dr Manish Bhatnagar Bhatnagars Clinic 2nd Floor, Kamdhenu Complex, Toran Dining Hall Lane, Opp. Sales, Ahmadabad GUJARAT Dr Pravin Rathi BYL Nair hospital Dr. A. L. Nair Road, Central Dr Aejaz Habeeb Dr Amol Bapaye Deccan College of Medical Sciences Deenanath Mangeshkar Hospital department, Kanchanbagh, Hyderabad Hyderabad Near Mhatre Bridge, Erandawane, Pune Pune Dr Sandeep Nijhawan Dr Nijhawans Clinic 112, Panchsheel Enclave, Gokul Bhai Bhatt Marg, Durgapura. Jaipur Rajasthan. Jaipur RAJASTHAN aigindia@yahoo.co.in bhatnagar@yahoo.com rathipm@gmail.com aejazhabeeb@hotmail. com amolbapaye@vsnl.com drnijhawansandeep@g mail.com Dr Ajay Kumar Dr. Ajay Kumar Dr. Ajay Kumar page 2 / 6

3 Chaudhary Chaudhary Clinic Chaudhary Clinic, Zeiniss Health Centre, Zeiniss Hospital Campus, Vivek Khand-2, Gomti Nagar Lucknow Uttar Pradesh.. Lucknow UTTAR PRADESH Dr Bhabadev Goswamy Institute of Digestive & Liver Disease, Dispur Hospital Ltd Dr Umesh Jalihal Dr B V Tantry Dr Murali Krishna Dr Shrikant Mukewar Dr Rajiv Kumar Shrivastava Dr Nitin Borse Dr Vinay Thorat Karnataka Center Kasturba Medical College Manikya Institute of Midas Institute of Nagarjuna Hospital Nasik Digestive Disease & Endoscopy Centre Poona Hospital and Research Centre Dispur Hospitals Limited Ganeshguri,Guwahati, Kamrup ASSAM 887, Dr. Modi Hospital Road,,Basaveshwarna gar Bangalore KARNATAKA Dr. Ambedkar Circle, Mangalore Karnataka Udupi KARNATAKA 203/204, MVV Chambers,Opposite KGH O P gate Visakhapatnam 4 Floor, Midas Heights, 07, Central bazar road, Ramdaspeth, Nagpur Nagpur department, Nagarjuna Hospital, Kanuru, Vijayawada Krishna 1st Floor, Rajeev Enclave, Besides Old Corporation Building,New Pandit Colony Nashik 27, Sadashiv Peth,, Pune Dr Meenu Hariharan PRS Hospital department, Killipalam, Trivandrum Kerala, Thiruvananthapuram KERALA drakchaudhary@yahoo. co.in bhabadev@rediffmail.c om drumeshj@yahoo.com tantrybv@gmail.com murlikrishna63@yahoo. com shrikant_mukewar@ya hoo.com rajshri73@yahoo.co.in nitinborse@hotmail.co m drvinaythorat@gmail.co m meenuhariharan@yaho o.com page 3 / 6

4 Details of Ethics Committee Dr Sheetal Dhadphale Ruby Hall Clinic 40, Sasoon Road, Pune Dr V G Mohan Prasad VGMS Endoscopy Center VGM Hospital 2100, Trichy Road, Rajalakshmi Mills Stop, Coimbatore , Tamil Nadu,. Coimbatore TAMIL NADU sheetal_dhadphale@ho tmail.com drvgm@rediffmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Medical Research Ethics Committee, Nagpur Approved 10/10/2009 Yes CLINICON IEC Approved 25/09/2009 Yes Coimbatur Ethics Committe, Tamilnadu Ethics Committe, Dispur Hospital Ltd Ethics Committee Asian Instutute of Ethics Committee of BYL Nair Hospital & TN Medical College Ethics Committee: PRS Hospital, Trivandrum, Kerala Independent Ethics Committee Mehta hospital Institutioanal Ethics Committe, Kasturba Medical College Institutioanl Ethics Committe, Ruby Hall Clinic, Pune Institutioanl Ethics Committee, andhra Medical College Approved 21/08/2009 Yes Approved 03/09/2009 Yes Approved 29/09/2009 No Approved 22/09/2009 No Approved 17/08/2009 No Approved 24/08/2009 Yes Approved 22/10/2009 No Approved 12/09/2009 No Approved 20/10/2009 Yes Institutional Ethical Research Committee of Deenanath Mangeshkar Hospital & Research Centre Approved 27/10/2009 No Institutional Ethics Committe Deccan College of Medical Sciences & Hospital Lucknow Independent Ethics Committe Nagarjuna Hospital, Kanuru, Vijaywada, Andhra Pradesh Approved 01/09/2009 No Approved 21/10/2009 Yes Approved 10/08/2009 No page 4 / 6

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Sanjeevani ethics Committe Shatabdi Hospital Ethics Committee The Ethics Committe, Poona Hospital & Research Centre, Pune Status Approved 30/10/2009 Yes Approved 11/08/2009 Yes Approved 12/08/2009 No Date Approved/Obtained 11/08/2009 Health Type Patients Condition Ulcerative Colitis Type Details Intervention Budesonide-MMX 6 mg or 9 mg for 56 days Comparator Agent Asacol and Placebo Asacol 2400 mg or Placebo for 56 days Age From Age To Gender Details Details Year(s) Year(s) Both Computer generated randomization Centralized Participant and Outcome Assessor Blinded Inclusion Criteria Adult males or females aged between 18 and 75 years of age, suffering from mild or moderate, active Ulcerative colitis for at least 6 months. Diagnosis of Ulcerative colitis with Ulcerative Colitis Disease Activity Index (UCDAI)more than or equal to 4 and less than or equal to 10. All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment and also throughout the entire study period. Exclusion Criteria Patients with limited distal proctitis, severe ulcerative colitis (UCDAI > 10), infectious colitis, evidence or history of toxic megacolon, severe anemia, leucopenia or granulocytopenia, intolerance to salicylates, liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoral parameters. Patients diagnosed with type 1 diabetes, glaucoma, Hepatitis B, Hepatitis C, HIV. Use of oral or rectal steroids in the last 4 weeks, use of immuno-suppressive agents in the last 8 weeks before the study, use of anti-tnf alpha agents in the last 3 months. Concomitant use of any rectal preparation, antibiotics, CYP3A4 inducers or inhibitors. Primary Outcome Outcome Timepoints Clinical remission in each of the Budesonide-MMX groups versus the placebo group 8th week Secondary Outcome Outcome Timepoints % of patients with a score of 0 for both rectal bleeding and stool frequency as defined by the 4th week and 8th week page 5 / 6

6 Powered by TCPDF ( Target Sample Size CAI. 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 % of patients achieving clinical improvement (UCDAI drop > or = 3 points from baseline, including reduction in bleeding if baseline bleeding subscore is > or = 2). % of patients with endoscopic healing (Endoscopic Index score = 0) % of patients with mucosal healing (histological score 0-1 per Saverymutthu) Total Sample Size=510 Sample Size from =174 No Date Specified 20/08/2008 Years= Months=0 Days=0 Completed Completed none 8th week. 8th week 8th week This is a randomized, double-blind, double dummy, parallel group, multicentre trial comparing the safety and efficacy of Oral Budesonide-MMX 6 mg or 9 mg daily, Asacol 2400 mg and placebo for 8 weeks patients with mild or moderate, active ulcerative colitis. The study is presently planned as a global study that will include up to investigational sites in US, Canada and to enroll approximately 492 subjects. A maximum of 200 subjects are proposed to be recruited from approximately 20 sites in. The anticipated date of enrollment for the n arm is 30th Oct A subject will be considered to have entered the study once randomized. The primary objective of the study is to evaluate the clinical efficacy and safety of new oral Budesonide-MMX 6 mg and 9 mg oral tablets in patients with mild or moderate, active Ulcerative Colitis, when administered for 8 weeks, and compared to placebo. The secondary objectives are to evaluate the clinical efficacy and safety of Budesonide-MMX 6 mg and 9 mg oral tablets compared to a three times daily oral dose of Asacol tablets (2 x 400 mg three times daily); and to evaluate the improvement in rectal bleeding, endoscopic, histological, bio-humoral parameters and in the IBDQoL questionnaire. page 6 / 6