Overview

(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).