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

Launched by BAUSCH HEALTH AMERICAS, INC. · May 15, 2008

Keywords

ClinConnect Summary

Each patient will receive one of the following regimens in the morning after breakfast:

1. one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or
2. one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or
3. two placebo Asacol® over encapsulated tablets plus one placebo budesonide tablet, or
4. two Asacol® 400 mg over encapsulated tablets plus one placebo budesonide tablet, daily for 8 weeks.

Each patient will also receive on each day after the midday meal and after the evening meal either:

* two Asacol® 400 mg over-encapsula...

Gender

ALL

Eligibility 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 anemia, leucopenia or granulocytopenia.
• • 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 tumor 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 intolerance to salicylates.
• • 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-humoral 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).