| CTRI Number |
CTRI/2010/091/000387 [Registered on: 20/05/2010] |
| Last Modified On: |
15/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of the drug Asacol 4,8g/day (800 mg tables) in patients with active Ulceratice Colitis |
Scientific Title of Study
Modification(s)
|
A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol? 4.8 g/day (800 mg tablets) for the Treatment of Active Ulcerative Colitis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT01059344 |
ClinicalTrials.gov |
| TP0203 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Mukesh Kalla |
| Designation |
|
| Affiliation |
S.R. Kalla Memorial Gastro and General Hospital. |
| Address |
S.R. Kalla Memorial Gastro and General Hospital,
78, Dhuleshwar Garden, Behind HSBC BankSardar Patel Marg, C-Scheme,
Jaipur
RAJASTHAN
302 001
India |
| Phone |
9829050622 |
| Fax |
01414020622 |
| Email |
drmkalla@rediffmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Mukesh Kalla |
| Designation |
|
| Affiliation |
|
| Address |
S.R. Kalla Memorial Gastro and General Hospital,
78, Dhuleshwar Garden, Behind HSBC BankSardar Patel Marg, C-Scheme,
Jaipur
RAJASTHAN
302 001
India |
| Phone |
09829050622 |
| Fax |
01414020622 |
| Email |
drmkalla@rediffmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Tillotts Pharma AG
Baslerstrasse 15
4310 Rheinfelden
Switzerland
|
|
Primary Sponsor
Modification(s)
|
| Name |
Tillotts Pharma AG |
| Address |
Baslerstrasse, 15 4310 Rheinfelden, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Belarus
Turkey
Ukraine |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Rajkumar |
Life Line Hospitals |
5/639, Rajiv Gandhi Salai (OMR), Perungudi,-600096
Chennai
TAMIL NADU |
09840940288
chairman@lifelinehospitals.com |
| Dr.Satya Prakash |
M.S.Ramiah Medical college & Hospital |
New BEL road,MSRIT Post-560 054
Bangalore
KARNATAKA |
(0)9845017337
satyaprakashbs@gmail.com |
| Dr.Premashis Kar |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
B.L.Taneja block,Room No 101/127,-110 002
New Delhi
DELHI |
09811042164
premashishkar@gmail.com |
| Dr.Uma Devi |
Medwin Hospital |
Raghava ratna towers,Chirag ali lane,Nampally,-500 001
Hyderabad
ANDHRA PRADESH |
09849278271
umadevimalladi_66@yahoo.co.in |
| B.Prapakhar |
Osmania General Hospital |
Afzalgunj,-500 012
Hyderabad
ANDHRA PRADESH |
09848029112
bprabhakardr@yahoo.com |
| Dr.Mukesh Kalla |
S.R. Kalla Memorial Gastro & General Hospital |
78 Duleshwar Garden, Sardar Patel Marg, C scheme,-302001
Jaipur
RAJASTHAN |
09829050622
drmkalla@rediffmail.com |
| Dr.K.T.Shenoy |
Sree Gokulam Medical Centre & Research Foundation |
Karinchanti Road, Venjaramoodu, P O,-695 607
|
09447044364
drktshenoy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee: Lifeline multispeciality Hospital |
Approved |
| Institutiona Ethics Committee - Medwin Hospital |
Approved |
| M.S. Ramaiah Medical College and Teaching Hospital Ethical Review Board |
Approved |
| Maulana Azad Medical College and Associated Lok Nayak, |
Approved |
| OsmaniaMedical College Ethics Committee |
Approved |
| S R Kalla Memorial Ethical Committee for Human Research |
Approved |
| Sree Gokulam Medical College and Research Foundation Ethics Committee( A Unit of foundation of Non-resident Indians) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Active Ulcerative Colitis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Asacol? |
4.8 g/day (800 mg tablets administered BID) for 10 weeks |
| Comparator Agent |
Placebo |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects must meet each of the following criteria for enrolment into the study:
(1) Male or non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
(2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge. For subjects newly diagnosed with UC, histopathological evidence of chronic inflammation should be obtained and documented.
(3) Active UC defined by:
(a) modified UC-DAI score of 4-10 with
(b) sigmoidoscopy component score ≥ 2 and
(c) rectal bleeding component score ≥ 1
(4) Ability of subject to participate fully in all aspects of this clinical trial.
(5) Written informed consent must be obtained and documented. |
|
| ExclusionCriteria |
| Details |
Subjects who exhibit any of the following conditions are to be excluded from the study:
(1) Severe UC defined by the following criteria: ≥6 bloody stools daily with one or more of the following:
(a) oral temperature > 37.8°C or > 100.0°F
(b) pulse > 90/min
(c) hemoglobin < 10 g/dL
(2) Previously failed treatment with a mesalazine dose of > 2.0 g/day.
(3) Current relapse lasting > 6 weeks in the opinion of the investigator.
(4) Treatment with 5-ASA at a dose of > 2.0 g/day within 1 week prior to randomization.
(5) Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
(6) Treatment with immunosuppressants within 6 weeks prior to randomization.
(7) Treatment with infliximab or other biologics within 3 months prior to randomization.
(8) Treatment with systemic antibiotics for UC within 7 days prior to randomization.
(9) Treatment with probiotics within 7 days prior to randomization
(10) Treatment with anti-diarrheals within 7 days prior to randomization
(11) Treatment with nicotine patch within 7 days prior to randomization.
(12) Received any investigational drug within 30 days prior to randomization.
(13) History of colectomy or partial colectomy.
(14) History of definite dysplasia in colonic biopsies.
(15) Crohn’s disease.
(16) Known.bleeding disorders.
(17) Immediate or significant risk of toxic megacolon.
(18) Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
(19) Serum creatinine > 1.5 times the upper limit of the normal range.
(20) AST, ALT, total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
(21) Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject’s ability to participate fully in the study.
(22) History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
(23) Stools positive for clostridium difficile.
(24) Pregnant or lactating women.
(25) Prior enrolment in the current study and had received study treatment. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy endpoint is the proportion of subjects in clinical and endoscopic remission after 6 weeks of treatment. Clinical and endoscopic remission is defined as a modified UC-DAI score of ≤ 1 with a score of 0 for stool frequency and rectal bleeding, absence of urgency, and at least a 1-point reduction from baseline in the sigmoidoscopy score. If the subject withdraws early from the study prior to Week 6, the subject will be considered a non-remitter.
The proportion of subjects in clinical and endoscopic remission after 6 weeks of treatment will be compared between the Asacol? and placebo treatment groups using the chi-square test. The between treatment group difference will be calculated and two-sided 95% confidence interval will be obtained. The PP analysis set will also be analysed for primary efficacy endpoint.
|
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
|  The proportion of subjects achieving clinical and endoscopic remission at Week 10. If the subject withdraws early from the study, the subject will be considered a non-remitter.
 The proportion of subjects achieving clinical and endoscopic remission at both Week 6 and Week 10.
 The proportion of subjects achieving clinical remission at Week 6, defined as a score of 0 for stool frequency and rectal bleeding, and absence of urgency. If the subject withdraws early from the study prior to Week 6, the subject will be considered a non-remitter.
 The proportion of subjects achieving clinical improvement at Week 6, defined as a decrease of at least 3 points from baseline in the modified UC-DAI score. If the subject withdraws early from the study prior to Week 6, the subject will be considered a non-responder.
 The changes in modified UC-DAI score (baseline to EOT)
 The changes in sigmoidoscopic (mucosal) appearance (baseline to EOT)
 The changes in rectal bleeding and stool frequency (baseline to EOT)
 The changes in UCCS (baseline to EOT) |
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="280"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
22/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
05/12/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The primary objective of the study is to determine the efficacy of Asacol? 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC). Secondary objectives of the study are to determine the efficacy of Asacol? 4.8 g/day (800 mg tablets) compared to placebo, by:  the proportion of subjects achieving clinical and endoscopic remission at Week 10  the proportion of subjects achieving clinical and endoscopic remission at both Week 6 and Week 10  the proportion of subjects achieving clinical remission at Week 6  the proportion of subjects achieving clinical improvement at Week 6  the changes in modified UC disease activity index (UC-DAI)  the changes in sigmoidoscopic appearance  the changes in rectal bleeding and stool frequency  the changes in ulcerative colitis clinical score (UCCS) The safety and tolerability of Asacol? 4.8 g/day (800 mg tablets) compared with placebo will also be evaluated. Planned first patient enrollment in India is end of May 2010. Approximately 112 patients from India will be recruited. |