TP05 for the Treatment of Mild to Moderate Active UC
This trial has been completed.
|Condition||acute ulcerative colitis|
|Sponsor||Tillotts Pharma AG|
|Start date||July 2013|
|End date||May 2016|
|Trial size||800 participants|
|Trial identifier||NCT01903252, TP0503|
The purpose of this research study is to compare the medication TP05 to the medication Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and tolerability of TP05. This study will investigate whether TP05 is as good as (non-inferior to) Asacol™.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Clinical and endoscopic remission
time frame: 8 weeks Induction
time frame: week 38
proportion of patients in remission
time frame: week 38
Male or female participants at least 18 years old.
Induction phase - Main criteria for inclusion include: 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 randomisation, 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. 3. Active UC defined by: 1. Mayo score of ≥ 5 2. Sigmoidoscopy component score ≥ 2 confirmed by central review and 3. Rectal bleeding component score ≥ 1 4. Ability of the subject to participate fully in all aspects of this clinical trial. 5. Written informed consent must be obtained and documented. Induction Phase - Main criteria for exclusion include: 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: 1. oral temperature > 37.8 degrees C or > 100.0 degrees F 2. pulse > 90 beats/min 3. haemoglobin < 10 g/dL (2) Treatment with oral mesalamine at a dose of > 2.4 g/day within 4 weeks prior to randomisation. (3) Treatment with topical therapy (mesalamine or corticosteroids) within 2 weeks prior to randomisation (4) Treatment with systemic or rectal steroids within 4 weeks prior to randomisation. (5) Treatment with immunosuppressants within 6 weeks prior to randomisation. (6) Treatment with infliximab or other biologics within 3 months prior to randomisation. (7) Treatment with antibiotics within 7 days prior to randomisation. (8) Treatment with probiotics within 7 days prior to randomisation. (9) Treatment with anti-diarrhoeal treatment within 7 days prior to randomisation. (10) Treatment with nicotine patch within 7 days prior to randomisation. (11) Received any investigational drug within 30 days prior to randomisation. (12) History of colectomy or partial colectomy. (13) History of definite dysplasia in colonic biopsies. (14) Crohn's disease. (15) Immediate or significant risk of toxic megacolon. (16) Known bleeding disorders. (17) Hypersensitivity to salicylates, aspirin, sulfasalazine or mesalazine. (18) Serum creatinine > 1.5 times the upper limit of the normal range. (19) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range. (20) Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study. (21) 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. (22) Stools positive for Clostridium difficile toxin. (23) Pregnant or lactating women. (24) Prior enrolment in the study. OLE - Main criteria for inclusion include: 1. Attendance at the Week 8 visit and completion of disease activity assessments prior to enrolment in OLE at Week 12 (responders or remitters) or Week 8 (non-responders). 2. At least 75% compliance with study medication in the induction phase. OLE - Main criteria for exclusion include: (1) Withdrawal from the induction phase prior to the Week 8 visit.
|Official title||A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/d for the Treatment of Active Ulcerative Colitis|
|Principal investigator||Geert R D'Haens, MD|
|Description||This is a Phase 3, randomised, double-blind, active-controlled, multi-centre, non-inferiority trial to evaluate the safety and efficacy of 3.2 g of TP05/day compared to 3.2 g/day of Asacol™ with an open label extension to assess the long-term safety and tolerability of TP05 administered over a 26 week period. A total of 800 subjects with mildly to moderately active UC will be evaluated. Eligible subjects will be randomly assigned in a 1:1 ratio to receive 3.2 g/day of TP05 (administered once daily) or 3.2 g/day of Asacol™. The primary efficacy outcome will be assessed at Week 8. All subjects who respond to TP05/Asacol™ (response or remission) will continue receiving blinded study treatment for up to 12 weeks. After that, subjects can enroll in an Open Label Extension (OLE) for 26 weeks duration to receive TP05. Subjects failing to respond to study drug at the Week 8 visit can enroll in the OLE at week 8 and receive 4.8 g/day of TP05.|
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