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1 Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar :05:28 GMT) CTRI Number CTRI/2010/091/ [Registered on: 29/01/2010] - Last Modified On 23/12/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Single Arm Trial A clinical trial to study the safety & efficacy of the study drug in patients with ulcerative colitis To assess the Efficacy and Safety of Oral Budesonide-MMX 9mg Extended - release Tablets in patients with mild to moderate active ulcerative colitis,who fail to achieve clinical remission in study CB-01-02/01(parent 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) CB-01-02/06 Protocol Number Details of Principal Investigator Clininvent research pvt ltd Details Contact Person (Scientific Query) Clininvent Research Pvt. Ltd. Details Contact Person (Public Query) Clininvent Research Pvt. Ltd. page 1 / 5

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 3721 Valley Centre Drive, Suite 400 San Diego, CA List of Countries of Principal Investigator Dr Nageshwar Reddy Dr Aejaz Habeeb Dr Ajay Kumar Chaudhary of Site Site Phone// Asian Institute of Deccan College of Medical Sciences Dr. Ajay Kumar Chaudhary Clinic G-3-661,Somajiguda, Hyderabad Kanchanbagh, Hyderabad Zeniss Health Centre,Zeniss Hospital Campus,Vivek Khand-2,Gomti Nagar Lucknow UTTAR PRADESH Dr Manish Bhatnagar Dr. Bhatnagars Clinic 2nd Floor,Kamdhenu Complex,Opp. Toran Dining Hall Lane,Opp. Sales,Ashram Road Ahmadabad GUJARAT Dr Sandeep Nijhawan Dr. Nijhawans Clinic 112,Panchsheel Enclave,Gokul Bhai Bhatt Marg,Durgapur Jaipur RAJASTHAN Dr Bhabadev Goswami Dr Umesh Jalihal Dr BV Tantry Institute of Digestive & Liver Diseases Karnataka Center Kasturba Medical College & Hospital Dispur Hospitals Limite d,ganeshguri Kamrup ASSAM aigindia@yahoo.co.in aejazhabeeb@hotmail. com drakchaudhary@yahoo. co.in man_bhatnagar@yaho o.com drnirjhawansandeep@g mail.com Bhabadev@rediffmail.c om #887,Dr. Modi Hospital Road,,Basaveshwarnag ar drumeshj@yahoo.com Bangalore KARNATAKA Dr. Ambedkar Circle, Bangalore tantrybv@gmail.com page 2 / 5

3 Details of Ethics Committee Dr Murali Krishna Dr Shrikant Mukewar Dr Rajeev Kumar Shrivastava Dr Nitin Borse Dr Vinay Thorat Manikya Institute of Midas Institute of Nagarjuna Hospital Nasik Digestive Disease & Endoscopy Centre Poona Hospital and Research Centre KARNATAKA 203/204,MVV Chambers,Opp. KGH O.P. Gate Bus Stop, Visakhapatnam com 4th Floor,Midas Heights,07,Central Bazar Road,Ramdaspet h hoo.com Nagpur Nagarjuna Hospital,Kanuru Krishna 1st floor,rajeev Enclave,Besides Old Corporation Building., New Pandit Colony Nashik 27, Sadashiv Peth, Pune Dr Meenu Hariharan PRS Hospital Department of gastroenterology, Killipalam Thiruvananthapuram KERALA Dr VG Mohan Prasad VGMs Endoscopy Center rajshri73@yahoo.co.in nitinborse@hotmail.co m drvinaythorat@gmail.co m meenuhariharan@yaho o.com Asoka Building,481/56,Dr. Nanjappa Road drvgm@rediffmail.com Coimbatore TAMIL NADU of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Medical Research Ethics Committee, Nagpur Approved 15/01/2010 Yes CLINICOM IEC Approved 10/12/2009 Yes Coimbatore Ethics Committee,Coimbatore Ethics Committe, Dispur Hospital Ltd Approved 22/01/2010 Yes Approved 05/11/2009 Yes Ethics Committee of Approved 01/02/2010 No Asian Institute of Gastro enterology,hyderabad Ethics Committee of Poona Hospital & Research Centre,Pune Ethics Committee: PRS Hospital, Trivandrum, Approved 12/02/2010 No Approved 01/12/2009 No page 3 / 5

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Kerala Independent Ethics Committee,Mehta Hospital,Ahmedabad Institutioanal Ethics Committe, Kasturba Medical College,Mangalore Institutional Ethics Committee,Andhra Medical College,Visakh apatnam,andhra Pradesh Institutional Ethics Committee,Deccan College of Medical Sciences,Hyderabad Lucknow Independent Ethics Committee,Lucknow Nagarjuna Hospital, Kanuru, Vijaywada, Andhra Pradesh Sanjeevani Ethics Committee,Rajasthan Approved 01/02/2010 Yes Approved 08/12/2009 No Approved 19/01/2010 Yes Approved 21/01/2010 No Approved 08/03/2010 Yes Approved 17/11/2009 No Approved 03/02/2010 Yes Shatabdi Hospital Approved 18/11/2009 Yes Ethics Committee,Nasik Status Date Approved/Obtained 19/01/2010 Health Type Patients Condition Ulcerative Colitis Type Details Intervention Budesonide-MMX 9mg tablet in the morning after breakfast for 8 weeks Comparator Agent NIL NIL Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Males and females aged between 18 and 75 years of age, who are able to understand & provide written informed consent. Completed all final visit assessments for study CB-01-02/01 and are not in clinical remission. Diagnosis of Ulcerative colitis of mild to moderate severity with Ulcerative Colitis Disease Activity Index less than or equal to 10 according to Sutherland. Females of child-bearing potential must have a serum pregnancy test performed at the final visit of the parent study and must use an acceptable contraceptive method thoughout the treatment period. Ability to comprehend the full nature and purpose of the study,including possible risks and side effects. Ability to co-operate with the investigator and to comply with the requirements of the entire study. Exclusion Criteria page 4 / 5

5 Powered by TCPDF ( Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Not Applicable Not Applicable Open Label Did not complete study CB-01-02/01 Achieved clinical remission in study CB-01-02/01 Patients with severe ulcerative colitis (UCDAI > 10), infectious colitis, evidence or history of toxic megacolon, severe anemia, leucopenia or granulocytopenia Use of immunosuppressive agents in the last 8 weeks before study,use of anti-tumour necrosis factor alpha agents in the last 3 months Concomitant use of any rectal preparation for the treatment of ulcerative colitis,antibiotics Concurrent use of CYP3A4 inducers and CYP3A4 inhibitors Patients with verified,presumed or expected pregnancy or ongoing lactation,liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoral parameters,severe disease(s) in other organs or systems,local or systemic complications or pathological states requiring a therapy with corticisteroids and/or immunosuppressive agents. Patients diagnosed with type 1 diabetes, glaucoma, Hepatitis B, Hepatitis C, HIV acording to the local privacy policy. Any other medical condition that in the principal investigator's opinion would make the administration of the study or study procedures hazardous to the subject or obscure the interpretation of adverse events. Primary Outcome Outcome Timepoints Clinical remission defined as a UCDAI score 1 with a score of 0 for both rectal bleeding & stool frequency and a 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability 8 weeks 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 CAI score of less than 4 UCDAI score IBD QoL questionnaire score Total Sample Size=100 Sample Size from =100 No Date Specified 08/02/2010 Years=0 Months=2 Days=0 Completed Completed none 8 weeks This study is an open label,multicenter trial to assess the safety & efficacy of oral Budesonide-MMX 9mg extended release tablets for 8 weeks in patients with mild to moderate ulcerative colitis who failed to achieve clinical remission in the parent study CB This study will be conducted only in in approximately 100 patients from approximately 20 centers in only.the primary endpoint is clinical remission after 8 weeks of treatment defined as a UCDAI score & the secondary outcome at 8 weeks are based on CAI score,ucdai score & IBD_QoL questionnaire score. page 5 / 5