A clinical trial to study the effects of the drug Asacol 4,8g/day (800 mg tables) in patients with active Ulceratice Colitis
- Conditions
- Health Condition 1: null- Active Ulcerative Colitis
- Registration Number
- CTRI/2010/091/000387
- Lead Sponsor
- Tillotts Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 280
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.
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) Crohnâ??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 subjectâ??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 subjectâ??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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 &#8804; 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.<br>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.<br>Timepoint:
- Secondary Outcome Measures
Name Time Method