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

Last updated: November 26, 2019
Sponsor: Bausch Health Americas, Inc.
Overall Status: Completed

Phase

3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT01100112
CB-01-02/06
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  • Male and female patients 18 to 74 years of age, who are able to understand andvoluntarily provide written informed consent

  • Completed all Final Visit assessments for study CB-01-02/01 (NCT00679432) and are notin clinical remission

  • Diagnosis of ulcerative colitis of mild to moderate severity with an UlcerativeColitis Disease Activity Index (UCDAI) <or= 10 according to Sutherland

  • Females of child-bearing potential must have had a serum pregnancy test performed atthe Final Visit of the parent study, and must use an acceptable contraceptive methodthroughout the treatment period. Female subjects must also not be activelybreast-feeding through the entire study period.

  • Ability to comprehend the full nature and purpose of the study, including possiblerisks and side effects

  • Ability to co-operate with the investigator and to comply with the requirements of theentire study

Exclusion

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 insufficiencyand/or severe impairment of the bio-humoral parameters (i.e., 2x upper limit of normalfor alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltranspeptidase, or creatinine)

  • Patients with severe disease(s) in other organs of systems

  • Patients with local of systemic complications of other pathological states requiring atherapy 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 makethe administration of the study drug or study procedures hazardous to the subject orobscure the interpretation of adverse events

Study Design

Total Participants: 61
Study Start date:
February 01, 2010
Estimated Completion Date:
August 31, 2010

Study 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.

Connect with a study center

  • Santarus Clinical Investigational Site 9001

    Andhra Pradesh,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9009

    Andhra Pradesh,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9012

    Andhra Pradesh,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9016

    Andhra Pradesh,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9006

    Assam,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9007

    Gujarat,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9004

    Karnataka,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9015

    Karnataka,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9003

    Kerala,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9002

    Maharashtra,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9008

    Maharashtra,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9013

    Maharashtra,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9018

    Rajasthan,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9005

    Tamil Nadu,
    India

    Site Not Available

  • Santarus Clinical Investigational Site 9014

    Uttar Pradesh,
    India

    Site Not Available

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