Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND

• Conditions: Mild to moderate ulcerative colitis.; MedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitis

• Registration Number: EUCTR2008-003913-28-IT
• Lead Sponsor: COSMO TECHNOLOGIES LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male and female patients, 18-75 years old, who are able to understand and voluntarily provide written informed consent. 2. 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). 3. Patients who have completed all End of Study assessments for study CB-01-02/01 and CB 01 02/02. 4. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who have withdrawn from studies CB-01-02/01 and CB 01 02/02. 2. 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 ≤ 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]). 3. Subjects with bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To evaluate the long-term safety and tolerability of budesonide-MMXTM 6 mg. 2. To collect data on the efficacy of budesonide-MMXTM 6 mg in the maintenance of remission versus placebo.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is the percentage of patients in 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 frequency over the normal for the patient.