(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period.

After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Cosmo Technologies Ltd
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Patients fulfilling the following criteria at the screening visit are eligible for participation in the study:

• Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months.

• Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to Sutherland.

• All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment. In addition, all females of child-bearing potential must agree to be completely abstinent or be using an accepted form of contraception throughout the entire study period. Accepted forms of contraception are defined as those with a failure rate <1% when properly applied and include: combination oral pill, some intra-uterine devices, and a sterilised partner in a stable relationship. Female subjects must also not be actively breast-feeding through the entire study 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.

• Must be able to understand and voluntarily sign written informed consent prior to inclusion in the study.

Exclusion Criteria:

• Patients who meet any of the following criteria at screening visit are to be excluded from study participation:

• Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line).

• Patients with severe ulcerative colitis (UCDAI >10).

• Patients with infectious colitis.

• Evidence or history of toxic megacolon.

• Severe anaemia, leucopaenia or granulocytopaenia.

• 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 tumour necrosis factor alpha (anti-TNFα) agents in the last 3 months.

• Concomitant use of any rectal preparation.

• Concomitant use of antibiotics.

• Concurrent use of cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors.

• Patients with verified, presumed or expected pregnancy or ongoing lactation.

• Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoural parameters (i.e. 2 x upper limit of normal for alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT) or creatinine).

• Patient with severe diseases in other organs and systems.

• Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents.

• Patients diagnosed with type 1 diabetes.

• Patients diagnosed with, or with a family history of, glaucoma.

• All patients with known hepatitis B, hepatitis C or with human immunodeficiency virus (HIV), according to the local privacy policy.

• Participation in experimental therapeutic studies in the last 3 months. (Note:

patients who participated in observational only studies are not excluded).

• Any other medical condition that in the principal investigator's opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events (AEs).