(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets

Bausch Health

Status and phase

Completed

Phase 3

Conditions

Colitis, Ulcerative

Treatments

Drug: Budesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01100112

CB-01-02/06

Details and patient eligibility

About

Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study [NCT00679432]).

Full description

Patients who complete the parent study and who do not achieve clinical remission will be eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy the entry criteria for this study.

Enrollment

61 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients 18 to 74 years of age, who are able to understand and voluntarily provide written informed consent
Completed all Final Visit assessments for study CB-01-02/01 (NCT00679432) and are not in clinical remission
Diagnosis of ulcerative colitis of mild to moderate severity with an Ulcerative Colitis Disease Activity Index (UCDAI) <or= 10 according to Sutherland
Females of child-bearing potential must have had a serum pregnancy test performed at the Final Visit of the parent study, and must use an acceptable contraceptive method throughout the treatment period. 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

Exclusion criteria

Did not complete study CB-01-02/01
Achieved clinical remission in study CB-01-02/01
Patients with severe ulcerative colitis (UCDAI >10)
Patients with infectious colitis
Evidence or history of toxic megacolon
Severe anemia, leucopenia, or granulocytopenia
Use of immunosuppressive agents in the last 8 weeks before the study
use of anti-tumor necrosis factor alpha agents in the last three months
Concomitant use of any rectal preparation for the treatment of ulcerative colitis
Concomitant use of antibiotics
Concurrent use of cytochrome P-450 3A4 (CYP3A4) inducers and CYP3A4 inhibitors.
Patients with verified, presumed of 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., 2x upper limit of normal for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or creatinine)
Patients with severe disease(s) in other organs of systems
Patients with local of systemic complications of other pathological states requiring a therapy with corticosteroids and/or immunosuppressive agents
Patients diagnosed with Type 1 diabetes
Patients diagnosed with or with a family history of glaucoma
Patients with known hepatitis B, hepatitis C, or with human immunodeficiency virus (HIV), according to the local privacy policy
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