A clinical trial to study the safety and effectiveness of the drug in patients with Ulcerative colitis.
- Conditions
- Health Condition 1: null- Ulcerative Colitis
- Registration Number
- CTRI/2009/091/000675
- Lead Sponsor
- COSMO Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 510
Adult males or females aged between 18 and 75 years of age, suffering from mild or moderate, active Ulcerative colitis for at least 6 months.
Diagnosis of Ulcerative colitis with Ulcerative Colitis Disease Activity Index (UCDAI)more than or equal to 4 and less than or equal to 10.
All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment and also throughout the entire study period.
Patients with limited distal proctitis, severe ulcerative colitis (UCDAI > 10), infectious colitis, evidence or history of toxic megacolon, severe anemia, leucopenia or granulocytopenia, intolerance to salicylates, liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoral parameters.
Patients diagnosed with type 1 diabetes, glaucoma, Hepatitis B, Hepatitis C, HIV.
Use of oral or rectal steroids in the last 4 weeks, use of immuno-suppressive agents in the last 8 weeks before the study, use of anti-TNF alpha agents in the last 3 months.
Concomitant use of any rectal preparation, antibiotics, CYP3A4 inducers or inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical remission in each of the Budesonide-MMX groups versus the placebo groupTimepoint: 8th week
- Secondary Outcome Measures
Name Time Method % of patients achieving clinical improvement (UCDAI drop > or = 3 points from baseline, including reduction in bleeding if baseline bleeding subscore is > or = 2).Timepoint: 8th week.;% of patients with a score of 0 for both rectal bleeding and stool frequency as defined by the CAI.Timepoint: 4th week and 8th week;% of patients with endoscopic healing (Endoscopic Index score = 0)Timepoint: 8th week;% of patients with mucosal healing (histological score 0-1 per Saverymutthu)Timepoint: 8th week