Status:
COMPLETED
(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Cosmo Technologies Ltd
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Detailed Description
Each patient will receive one of the following regimens in the morning after breakfast: 1. One budesonide MMX® 6 mg tablet plus three placebo Entocort enteric-coated (EC®) overencapsulated capsules, ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT00679380
Start Date
June 1 2008
End Date
April 1 2010
Last Update
December 10 2019
Active Locations (71)
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1
Centre for Digestive Diseases
Sydney, New South Wales, Australia, 2046
2
Royal Adelaide Hospital
Adelaide, Australia, 5000
3
Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,
Box Hill, Australia, VIC 3128
4
The Alfred Hospital
Melbourne, Australia, 3004