Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar 2019 02:05:28 GMT) CTRI Number CTRI/2010/091/000068 [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
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. 42-43 Amiens Street Dublin 1 Ireland > Santarus, Inc. 3721 Valley Centre Drive, Suite 400 San Diego, CA 92130 Type of Sponsor Primary Sponsor Details COSMO Technologies Ltd 42-43 Amiens StreetDublin 1Ireland Pharmaceutical industry-global Santarus Inc 3721 Valley Centre Drive, Suite 400 San Diego, CA 92130 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,-5 00082 Hyderabad Kanchanbagh,-500058 Hyderabad Zeniss Health Centre,Zeniss Hospital Campus,Vivek Khand-2,Gomti Nagar-26010 Lucknow UTTAR PRADESH Dr Manish Bhatnagar Dr. Bhatnagars Clinic 2nd Floor,Kamdhenu Complex,Opp. Toran Dining Hall Lane,Opp. Sales,Ashram Road-380009 Ahmadabad GUJARAT Dr Sandeep Nijhawan Dr. Nijhawans Clinic 112,Panchsheel Enclave,Gokul Bhai Bhatt Marg,Durgapur-302017 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-781006 Kamrup ASSAM 91-40-23378888 91-40-23324255 aigindia@yahoo.co.in 40-24342954 40-24342954 aejazhabeeb@hotmail. com 522-2258672 drakchaudhary@yahoo. co.in 79-27542966 79-27543880 man_bhatnagar@yaho o.com 2560994 drnirjhawansandeep@g mail.com 9864094739 Bhabadev@rediffmail.c om #887,Dr. Modi Hospital 80-41535195 Road,,Basaveshwarnag 80-41535195 ar-560086 drumeshj@yahoo.com Bangalore KARNATAKA Dr. Ambedkar Circle,-575001 Bangalore 8242444590 tantrybv@gmail.com page 2 / 5
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,-530002 Visakhapatnam 9849129394 murlikrishna63@yahoo. com 4th Floor,Midas 91-712-2434242 Heights,07,Central Bazar Road,Ramdaspet shrikant_mukewar@ya h-440010 hoo.com Nagpur Nagarjuna Hospital,Kanuru-52000 7 Krishna 1st floor,rajeev Enclave,Besides Old Corporation Building., New Pandit Colony-422002 Nashik 27, Sadashiv Peth,-411030 Pune Dr Meenu Hariharan PRS Hospital Department of gastroenterology, Killipalam 695002 Thiruvananthapuram KERALA Dr VG Mohan Prasad VGMs Endoscopy Center 866-2554701 866-2554169 rajshri73@yahoo.co.in 253-2574070 253-2574070 nitinborse@hotmail.co m 020-66096000 020-24339352 drvinaythorat@gmail.co m 471-2344443 meenuhariharan@yaho o.com Asoka 9842204995 Building,481/56,Dr. Nanjappa Road-641018 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
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 18.00 Year(s) 75.00 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
Powered by TCPDF (www.tcpdf.org) 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-01-02-01.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