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CTRI Number  CTRI/2010/091/000068 [Registered on: 29/01/2010]
Last Modified On: 11/03/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
A Multicenter,Open-Label Efficacy And Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients with Mild to Moderate,Active Ulcerative Colitis 
Scientific Title of Study
Modification(s)  
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
Modification(s)  
Secondary ID  Identifier 
CB-01-02/06  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Arun Bhatt 
Designation  President 
Affiliation  Clininvent research pvt ltd 
Address  A-103, Everest Chambers
Marol Naka, Andheri (E)
Mumbai
MAHARASHTRA
400 059
India 
Phone  022-67818666  
Fax    
Email  arunbhatt@clininvent.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Arun Bhatt 
Designation  President 
Affiliation  Clininvent Research Pvt. Ltd. 
Address  A-103, Everest Chambers
Marol Naka, Andheri (E)
Mumbai
MAHARASHTRA
400 059
India 
Phone  022-67818666  
Fax    
Email  arunbhatt@clininvent.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Arun Bhatt 
Designation  President 
Affiliation  Clininvent Research Pvt. Ltd. 
Address  A-103, Everest Chambers
Marol Naka, Andheri (E)
Mumbai
MAHARASHTRA
400 059
India 
Phone  022-67818666  
Fax    
Email  arunbhatt@clininvent.com  
 
Source of Monetary or Material Support
Modification(s)  
COSMO Technologies Ltd. 42-43 Amiens Street Dublin 1 Ireland  
Santarus, Inc. 3721 Valley Centre Drive, Suite 400 San Diego, CA 92130 
 
Primary Sponsor
Modification(s)  
Name  COSMO Technologies Ltd 
Address  42-43 Amiens StreetDublin 1Ireland 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Santarus Inc  3721 Valley Centre Drive, Suite 400 San Diego, CA 92130 
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study  
No of Sites = 23  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Vineet Ahuja  All India Institute ofMedical Sciences  Ansari Nagar,-110029
New Delhi
DELHI 


vins_ahuja@hotmail.com 
Dr. Nageshwar Reddy  Asian Institute of Gastroenterology  G-3-661,Somajiguda,-500082
Hyderabad
ANDHRA PRADESH 
+91-40-23378888
+91-40-23324255
aigindia@yahoo.co.in 
Dr. Pravin Rathi  BYL Nair Hospital  Dr. A.L. Nair Road,,Mumbai Central-40008
Mumbai
MAHARASHTRA 
+91-22-23086626

rathipm@gmail.com 
Dr. Ajit Sood  Dayanand Medical College & Hospital  Tagore Nagar,Civil Lines-141001
Ludhiana
PUNJAB 
+91-9815400718
+91-161-2300791
 
Dr. Aejaz Habeeb  Deccan College of Medical Sciences  Kanchanbagh,-500058
Hyderabad
ANDHRA PRADESH 
+91-40-24342954
+91-40-24342954
aejazhabeeb@hotmail.com 
Dr. Amol Bapaye  Deenanath Mangeshkar Hospital  Erandawane,-411004
Pune
MAHARASHTRA 
+91-20- 40151163

amolbapaye@vsnl.com 
Dr. Ajay Kumar Chaudhary   Dr. Ajay Kumar Chaudhary Clinic  Zeniss Health Centre,Zeniss Hospital Campus,Vivek Khand-2,Gomti Nagar-26010
Lucknow
UTTAR PRADESH 
+91-522-2258672
+91-522-4082666
drakchaudhary@yahoo.co.in 
Dr. Manish Bhatnagar  Dr. Bhatnagar's Clinic  2nd Floor,Kamdhenu Complex,Opp. Toran Dining Hall Lane,Opp. Sales India,Ashram Road-380009
Ahmadabad
GUJARAT 
+91-79-27542966
+91-79-27543880
man_bhatnagar@yahoo.com 
Dr. Sandeep Nijhawan  Dr. Nijhawan's Clinic  112,Panchsheel Enclave,Gokul Bhai Bhatt Marg,Durgapur-302017
Jaipur
RAJASTHAN 
+91-141-2560994
+91-141-2560994
drnirjhawansandeep@gmail 
Dr. Bhabadev Goswami  Institute of Digestive & Liver Diseases  Dispur Hospitals Limited,Ganeshguri-781006

 
+91-9864094739

Bhabadev@rediffmail.com 
Dr. Umesh Jalihal  Karnataka Gastroenterology Center  #887,Dr. Modi Hospital Road,,Basaveshwarnagar-560086
Bangalore
KARNATAKA 
+91-80-41535195
+91-80-41535195
drumeshj@yahoo.com 
Dr. B.V. Tantry  Kasturba Medical College & Hospital  Dr. Ambedkar Circle,-575001
Bangalore
KARNATAKA 
+91-8242444590

tantrybv@gmail.com 
Dr. Murali Krishna  Manikya Institute of Gastroenterology  203/204,MVV Chambers,Opp. KGH O.P. Gate Bus Stop,-530002
Visakhapatnam
ANDHRA PRADESH 
+91-9849129394
+91-891-2781423
murlikrishna63@yahoo.com 
Dr. Shrikant Mukewar  Midas Institute of Gastroenterology  4th Floor,Midas Heights,07,Central Bazar Road,Ramdaspeth-440010
Nagpur
MAHARASHTRA 
+91-712-2434242

shrikant_mukewar@yahoo.com 
Dr. Rajeev Kumar Shrivastava  Nagarjuna Hospital  Nagarjuna Hospital,Kanuru-520007

 
+91-866-2554701
+91-866-2554169
rajshri73@yahoo.co.in 
Dr. Nitin Borse  Nasik Digestive Disease & Endoscopy Centre  1st floor,Rajeev Enclave,Besides Old Corporation Building., New Pandit Colony-422002

 
+91-253-2574070
+91-253-2574070
nitinborse@hotmail.com 
Dr. Ajit Kumar  Nizam's Institute of Medical Sciences  Punjagutta,-500082
Hyderabad
ANDHRA PRADESH 
+91-40-23320332

ajitkrs@yahoo.com 
Dr. Vinay Thorat  Poona Hospital and Research Centre  27, Sadashiv Peth,-411030
Pune
MAHARASHTRA 
+91-20-66096000
+91-20-24339352
drvinaythorat@gmail.com 
Dr. Usha Dutta  Post Graduate Institute of Medical Education & Research  Department of Gastroenterology,Sector-12,CGI-160012
Chandigarh
CHANDIGARH 
+91-172-2756610
+91-172-2744401
ushadutta@gmail.com 
Dr. Meenu Hariharan  PRS Hospital  Killipalam,-695002

 
+91-471-2344443

meenuhariharan@yahoo.com 
Dr. Sheetal Dhadphale  Ruby Hall Clinic  40,Sasoon Road,-411001
Pune
MAHARASHTRA 
+91-20-26123391

sheetal_dhadphale@hotmail.com 
Dr. Hemant Gupta  Samvedna Clinic  B27/88G,New Colony,Ravindra Puri -221005
Varanasi
UTTAR PRADESH 
+91-542-2420456

hemantg26@yahoo.com 
Dr. V.G. Mohan Prasad  VGM's Endoscopy Center  Asoka Building,481/56,Dr. Nanjappa Road-641018
Coimbatore
TAMIL NADU 
+91-9842204995
+91-422-2232935
drvgm@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 23  
Name of Committee  Approval Status 
Central India Medical Research Ethics Committee, Nagpur  Approved 
CLINICOM IEC  Approved 
Coimbatore Ethics Committee,Coimbatore  Not Applicable 
Ethics Committe, Dispur Hospital Ltd  Approved 
Ethics Committee of Asian Institute of Gastroenterology,Hyderabad  Approved 
Ethics Committee of BYL Nair Charitable Hospital and TN Medical College,Mumbai  Not Applicable 
Ethics Committee of Poona Hospital & Research Centre,Pune  Approved 
Ethics Committee: PRS Hospital, Trivandrum, Kerala  Approved 
Independent Ethics Committee,Mehta Hospital,Ahmedabad  Approved 
Institutioanal Ethics Committe, Kasturba Medical College,Mangalore  Approved 
Institutioanl Ethics Committe, Ruby Hall Clinic, Pune  Not Applicable 
Institutional Ethics Commitee,Dayanand Medical College & Hospital,Ludhiana,Punjab  Not Applicable 
Institutional Ethics Committee,AIIMS,New Delhi  Not Applicable 
Institutional Ethics Committee,Andhra Medical College,Visakhapatnam,Andhra Pradesh  Approved 
Institutional Ethics Committee,Deccan College of Medical Sciences,Hyderabad  Approved 
institutional Ethics committee,Deenanath Mangeshkar Hospital,Pune  Not Applicable 
Institutional Ethics Committee,Nizams Institute of Medical Sciences,Hyderabad  Not Applicable 
Lucknow Independent Ethics Committee,Lucknow  Approved 
Nagarjuna Hospital, Kanuru, Vijaywada, Andhra Pradesh  Approved 
PGI Ethics Committee,Chandigarh,Punjab  Not Applicable 
Samvedna Hospital Ethics Committee,Varanasi,U.P.  Not Applicable 
Sanjeevani Ethics Committee,Rajasthan  Approved 
Shatabdi Hospital Ethics Committee,Nasik  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Ulcerative Colitis 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Budesonide-MMX  9mg tablet in the morning after breakfast for 8 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  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 (UCDAI)< or = 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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking
Modification(s)  
Open Label 
Primary Outcome
Modification(s)  
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
Modification(s)  
Outcome  TimePoints 
CAI score of less than 4
UCDAI score
IBD QoL questionnaire score 
8 weeks 
 
Target Sample Size
Modification(s)  
Total Sample Size="100"
Sample Size from India="100" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)
Modification(s)  
No Date Specified 
Date of First Enrollment (Global)  08/02/2010 
Estimated Duration of Trial
Modification(s)  
Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
none 
Brief Summary
Modification(s)  
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 India in approximately 100 patients from approximately 20 centers in India 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. 
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