Mild to moderate ulcerative colitis. MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Conditions
Interventions
Product Name: Budesonide-MMX
Product Code: CB-01-02
Pharmaceutical Form: Tablet
INN or Proposed INN: Budesonide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
P
Sponsors
COSMO TECHNOLOGIES LTD
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 Subjects who have withdrawn from studies CB-01-02/01 and CB 01 02/02. 2.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed