Clinical Trial Details (PDF Generation Date :- Sat, 01 Dec 2018 00:07:49 GMT) CTRI Number CTRI/2010/091/000387 [Registered on: 20/05/2010] - Last Modified On 15/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A clinical trial to study the effects of the drug Asacol 4,8g/day (800 mg tables) in patients with active Ulceratice Colitis 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 Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) NCT01059344 TP0203 Designation Affiliation ClinicalTrials.gov Protocol Number Details of Principal Investigator Not Applicable N/A Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Dr Mukesh Kalla Phone 9829050622 Fax 01414020622 Email Designation Affiliation S.R. Kalla Memorial Gastro and General. S.R. Kalla Memorial Gastro and General, 78, Dhuleshwar Garden, Behind HSBC BankSardar Patel Marg, C-Scheme, Jaipur RAJASTHAN 302 001 drmkalla@rediffmail.com Details Contact Person (Public Query) Dr Mukesh Kalla Phone 09829050622 S.R. Kalla Memorial Gastro and General, 78, Dhuleshwar Garden, Behind HSBC BankSardar Patel Marg, C-Scheme, Jaipur RAJASTHAN 302 001 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Fax 01414020622 Email drmkalla@rediffmail.com Source of Monetary or Material Support > Tillotts Pharma AG Baslerstrasse 15 4310 Rheinfelden Switzerland Type of Sponsor List of Countries Belarus Turkey Ukraine of Principal Investigator Primary Sponsor Details Tillotts Pharma AG Baslerstrasse, 15 4310 Rheinfelden, Switzerland Pharmaceutical industry-global of Site Site Phone/Fax/Email Dr.Rajkumar Life Line s 5/639, Rajiv Gandhi Salai (OMR), Perungudi,-600096 Chennai TAMIL NADU Dr.Satya Prakash Dr.Premashis Kar M.S.Ramiah Medical college & Maulana Azad Medical College and Associated Lok Nayak New BEL road,msrit Post-560 054 Bangalore KARNATAKA B.L.Taneja block,room No 101/127,-110 002 New Delhi DELHI Dr.Uma Devi Medwin Raghava ratna towers,chirag ali lane,nampally,-500 001 Hyderabad ANDHRA PRADESH B.Prapakhar Dr.Mukesh Kalla Dr.K.T.Shenoy Osmania General S.R. Kalla Memorial Gastro & General Sree Gokulam Medical Centre & Research Foundation Afzalgunj,-500 012 Hyderabad ANDHRA PRADESH 78 Duleshwar Garden, Sardar Patel Marg, C scheme,-302001 Jaipur RAJASTHAN Karinchanti Road, Venjaramoodu, P O,-695 607 Not Applicable N/A 09840940288 chairman@lifelinehospit als.com (0)9845017337 satyaprakashbs@gmail. com 09811042164 premashishkar@gmail. com 09849278271 umadevimalladi_66@ya hoo.co.in 09848029112 bprabhakardr@yahoo.c om 09829050622 drmkalla@rediffmail.co m 09447044364 drktshenoy@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee: Lifeline multispeciality Approved 12/02/2010 No page 2 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Institutiona Ethics Committee - Medwin M.S. Ramaiah Medical College and Teaching Ethical Review Board Maulana Azad Medical College and Associated Lok Nayak, OsmaniaMedical College Ethics Committee S R Kalla Memorial Ethical Committee for Human Research Sree Gokulam Medical College and Research Foundation Ethics Committee( A Unit of foundation of Non-resident ns) Status Approved/Obtained Health Type Patients Approved 12/03/2010 No Approved 31/08/2010 No Approved 19/11/2010 No Approved 22/05/2010 No Approved 08/02/2010 No Approved 18/02/2010 No Date No Date Specified Condition Active Ulcerative Colitis Type Details Intervention Asacol? 4.8 g/day (800 mg tablets administered BID) for 10 weeks Comparator Agent Placebo Nil Age From Age To Gender Details 18.00 Year(s) 65.00 Year(s) Both Inclusion Criteria 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 page 3 / 6
Exclusion Criteria Details (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. Exclusion Criteria 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 (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 (5) Treatment with systemic or rectal steroids within 4 weeks prior to (6) Treatment with immunosuppressants within 6 weeks prior to (7) Treatment with infliximab or other biologics within 3 months prior to (8) Treatment with systemic antibiotics for UC within 7 days prior to (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 (12) Received any investigational drug within 30 days prior to (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 page 4 / 6
Method of Generating Random Sequence Method of Concealment Blinding/Masking range. Computer generated randomization Centralized (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. 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. 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 page 5 / 6
Powered by TCPDF (www.tcpdf.org) PDF of Trial 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 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) Total Sample Size=280 Sample Size from =112 22/06/2010 05/12/2009 Years=1 Months=0 Days=0 Completed Completed 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 is end of May 2010. Approximately 112 patients from will be recruited. page 6 / 6