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1 Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar :08:23 GMT) CTRI Number CTRI/2009/091/ [Registered on: 09/12/2009] - Last Modified On 15/09/2014 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, Placebo Controlled Trial A clinical trial to study the safety & efficacy of the study drug in patients with ulcerative colitis Randomised, Double-blind, Multi-centric, 12 Month Extension Study to Evaluate the Safety & Efficacy of Daily Budesonide MMX 6 mg Vs Placebo in the Maintenance of Remission in Subjects with Ulcerative Colitis 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-01-02/04 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 Fax 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 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 Primary Sponsor Details COSMO Technologies Ltd Amiens StreetDublin 1Ireland Pharmaceutical industry-global Santarus, Inc Valley Centre Drive, Suite 400 San Diego, CA List of Countries Canada United States of America of Principal Investigator Dr Nageshwar Reddy of Site Site Phone/Fax/ Asian Institute of G-3-661, Somajiguda, Hyderabad Hyderabad Dr Manish Bhatnagar Bhatnagars Clinic 2nd Floor, Kamdhenu Complex, Toran Dining Hall Lane, Opp. Sales, Ashram Road, Ahmedabad 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 Kanchanbagh, Hyderabad Hyderabad Near Mhatre Bridge, Erandawane, Pune Pune Dr Sandeep Nijhawan Dr NIjhawans Clinic 112, Panchsheel Enclave, Gokul Bhai Bhatt Marg, Durgapura. Jaipur Jaipur RAJASTHAN Dr Ajay Kumar Chaudhary Dr. Ajay Kumar Chaudhary Clinic Dr. Ajay Kumar Chaudhary Clinic, Zeiniss Health Centre, Zeiniss Hospital Campus, Vivek Khand-2, Gomti Nagar aigindia@yahoo.co.in bhatnagar@yahoo.com rathipm@gmail.com aejazhabeeb@hotmail. com amolbapaye@vsnl.com drnijhawansandeep@g mail.com drakchaudhary@yahoo. co.in page 2 / 6

3 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 Rajeev Kumar Shrivastava Dr Nitin Borse Dr Vinay Thorat Karnataka Center KMC Hospital, Magalore Manikya Institute of Midas Institute of Nagarjuna Hospital Nasik Digestive Disease & Endoscopy Centre Poona Hospital and Research Centre Lucknow Lucknow UTTAR PRADESH Dispur Hospitals Limited Ganeshguri,Guwahati, Kamrup ASSAM 887, Dr. Modi Hospital Road, Basaveshwarnagar, Bangalore Karnataka, Bangalore KARNATAKA Dr. Ambedkar Circle, Mangalore Karnataka Udupi KARNATAKA 203/204, MVV Chambers, Opposite KGH O P gate, Visakhapatnam Visakhapatnam 4 Floor, Midas Heights, 07, Central bazar road, Ramdaspeth, Nagpur ,. Nagpur Nagarjuna Hospital, Kanuru, Vijayawada Krishna 1st Floor, Rajeev Enclave, Besides Old Corporation Building, New Pandit Colony, Nasik Nashik 27, Sadashiv Peth, Pune Pune Dr Meenu Hariharan PRS Hospital Killipalam, Trivandrum Kerala, Thiruvananthapuram KERALA Dr Sheetal Dhadphale Ruby Hall Clinic 40, Sasoon Road, Pune Pune bhabadev@sify.com drumeshj@yahoo.com tantrybv@gmail.com muralikrishna63@yaho o.com shrikant_mukewar@ya hoo.com rajshri73@yahoo.co.in nitinborse@hotmail.co m drvinaythorat@gmail.co m meenuhariharan@yaho o.com sheetal_dhadphale@ho tmail.com page 3 / 6

4 Details of Ethics Dr VG Mohan Prasad VGM Hospital Institute of, No-2100, Trichy road, Rajalakshmi Mills stop, Singallur post Coimbatore TAMIL NADU of Approval Status Date of Approval Is Independent Ethics? Central Medical Research Ethics Committe, Nagpur CLINICON Ethics Coimbatore Ethics Ethics Committe, Nagarjuna Hospital Ethics, Asian Institute of Ethics, BYL Nair Hospital & TN Medical College Ethics, Dispur Hospital Ethics, Poona hospital & Research Centre Ethics, PRS hospital Independent Ethics Committe, Mehta Hospital, ahmedabad Institutioanal ethics Committe, Andhra Medical College Committe, Deccan College of Medical Sciences & Allied Hospitals, Hyderabad Committe, KMC, Mangalore - Poona Medical Research Foundation, Deenanath Mangeshkar Hospital & Research Centre Lucknow Independent Ethics Approved 20/10/2009 Yes Approved 12/10/2009 Yes Approved 22/01/2010 Yes Approved 21/09/2009 No Approved 29/09/2009 No Approved 19/11/2009 No Approved 05/11/2009 Yes Approved 11/12/2009 No Approved 01/12/2009 No Approved 24/10/2009 Yes Approved 20/10/2009 Yes Approved 22/10/2009 No Approved 22/10/2009 No Approved 30/09/2009 No Approved 12/01/2010 No Approved 05/11/2009 Yes Sanjeevani Ethics Approved 11/01/2010 Yes page 4 / 6

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Shatabdi Hospital Ethics Status Approved 02/10/2009 No Date Approved/Obtained 09/10/2009 Health Type Patients Condition Ulcerative Colitis Type Details Intervention Budesonide MMX 6 mg 6 mg orally, daily for 12 months Comparator Agent Placebo 1 placebo tablet daily for 12 months Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Male and female patients, years old, who are able to understand and voluntarily provide written informed consent. Patients in UCDAI remission defined as a UCDAI score? 1 point with a score of 0 for rectal bleeding and stool frequency, and a? 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance). Patients who have completed all End of Study assessments for the CB-01-02/01 & CB-01-02/02 studies Females of child-bearing potential must have had a serum pregnancy test performed at the End of Study visit of the parent studies and must use an acceptable contraceptive method throughout the study treatment period. Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Exclusion Criteria Details Subjects who have withdrawn from studies CB-01-02/01 and CB 01 02/02. Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01 and CB 01 02/02 (i.e. clinical remission defined as a UCDAI score 1 point with a score of 0 for rectal bleeding and stool frequency, and 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability [score 0 for mucosal appearance]). Subjects with abnormal bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans or alternative radiological method. Computer generated randomization Centralized Participant and Outcome Assessor Blinded Primary Outcome Outcome Timepoints The primary efficacy endpoint is the percentage 12 month of patients achieving clinical remission at 1, 3, 6, 9 and 12 months, where clinical remission is defined as the combined absence of recurrence of rectal bleeding and absence of increased stool page 5 / 6

6 Powered by TCPDF ( frequency Secondary Outcome Outcome Timepoints 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 Time to clinical relapse Percentage of patients in UCDAI remission at 12 months Percentage of patients in endoscopic relapse occurrence of glucocorticoid related AEs Total Sample Size=150 Sample Size from =26 06/01/ /01/2009 Years=0 Months=6 Days=0 Completed Completed No publication 12 months 12 months 12 months throughout study This is a randomised, double-blind, multi-centric, 12 month Extension Study to evaluate the safety & efficacy of daily Budesonide MMX 6 mg vs pacebo in the maintenance of remission in subjects with Ulcerative Colitis. The study is presently planned as a global study that will include up to 52 investigational sites in US, Canada and to enroll approximately 150 subjects. A maximum of 100 subjects are proposed to be recruited from approximately 25 sites in. The anticipated date of enrollment for the n arm is 15th Dec A subject will be considered to have entered the study once randomized. The primary objective of the study is to evaluate the long term efficacy and safety of oral Budesonide-MMX 6 mg tablets in the maintenance of remission in patients of ulcerative colitis who have already achieved remission in the paternt study (CB-01-02/01). The treatment period for individual patient will be 12 month & results will be compared to the Placebo arm. page 6 / 6