A clinical trial to study the safety & efficacy of the study drug in patients with ulcerative colitis
- Conditions
- Health Condition 1: null- Ulcerative Colitis
- Registration Number
- CTRI/2009/091/000901
- Lead Sponsor
- COSMO Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Male and female patients, 18-75 years old, who are able to understand and voluntarily provide written informed consent.
Patients in UCDAI remission defined as a UCDAI score <= 1 point with a score of 0 for rectal bleeding and stool frequency, and a >= 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance).
Patients who have completed all End of Study assessments for the CB-01-02/01 & CB-01-02/02 studies
Females of child-bearing potential must have had a serum pregnancy test performed at the End of Study visit of the parent studies and must use an acceptable contraceptive method throughout the study treatment period.
Subjects who have withdrawn from studies CB-01-02/01 and CB 01 02/02.
Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01 and CB 01 02/02 (i.e. clinical remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability [score 0 for mucosal appearance]).
Subjects with abnormal bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans or alternative radiological method.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is the percentage of patients achieving clinical remission at 1, 3, 6, 9 and 12 months, where clinical remission is defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequencyTimepoint: 12 month
- Secondary Outcome Measures
Name Time Method occurrence of glucocorticoid related AEsTimepoint: throughout study;Percentage of patients in endoscopic relapseTimepoint: 12 months;Percentage of patients in UCDAI remission at 12 monthsTimepoint: 12 months;Time to clinical relapseTimepoint: 12 months