| 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 |
| Contact Person |
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)
|
|
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. |