(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Budesonide
Intervention description: One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ulcerative colitis; Budesonide

Summary:

      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]).
    

Eligibility criteria:

        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