Health Condition 1: null- Ulcerative Colitis
Conditions
Interventions
Intervention1: Budesonide-MMX: 9mg tablet in the morning after breakfast for 8 weeks
Control Intervention1: NIL: NIL
Sponsors
COSMO Technologies Ltd
Santarus Inc
Eligibility
Inclusion criteria
Inclusion criteria: Males and females aged between 18 and 75 years of age, who are able to understand & provide written informed consent. Completed all final visit assessments for study CB-01-02/01 and are not in clinical remission. Diagnosis of Ulcerative colitis of mild to moderate severity with Ulcerative Colitis Disease Activity Index less than or equal to 10 according to Sutherland. Females of child-bearing potential must have a serum pregnancy test performed at the final visit of the parent study and must use an acceptable contraceptive method thoughout the treatment period. Ability to comprehend the full nature and purpose of the study,including possible risks and side effects. Ability to co-operate with the investigator and to comply with the requirements of the entire study.
Exclusion criteria
Exclusion criteria: Did not complete study CB-01-02/01 Achieved clinical remission in study CB-01-02/01 Patients with severe ulcerative colitis (UCDAI > 10), infectious colitis, evidence or history of toxic megacolon, severe anemia, leucopenia or granulocytopenia Use of immunosuppressive agents in the last 8 weeks before study,use of anti-tumour necrosis factor alpha agents in the last 3 months Concomitant use of any rectal preparation for the treatment of ulcerative colitis,antibiotics Concurrent use of CYP3A4 inducers and CYP3A4 inhibitors Patients with verified,presumed or expected pregnancy or ongoing lactation,liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoral parameters,severe disease(s) in other organs or systems,local or systemic complications or pathological states requiring a therapy with corticisteroids and/or immunosuppressive agents. Patients diagnosed with type 1 diabetes, glaucoma, Hepatitis B, Hepatitis C, HIV acording to the local privacy policy. Any other medical condition that in the principal investigator's opinion would make the administration of the study or study procedures hazardous to the subject or obscure the interpretation of adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission defined as a UCDAI score 1 with a score of 0 for both rectal bleeding & stool frequency and a 1 point reduction from baseline in endoscopy score, without any sign of mucosal friabilityTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| CAI score of less than 4 UCDAI score IBD QoL questionnaire scoreTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Arun Bhatt
Clininvent Research Pvt. Ltd.
Outcome results
None listed