Phase
Condition
Crohn's Disease
Inflammatory Bowel Disease
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
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
Study Description
Connect with a study center
Santarus Clinical Investigational Site 9001
Andhra Pradesh,
IndiaSite Not Available
Santarus Clinical Investigational Site 9009
Andhra Pradesh,
IndiaSite Not Available
Santarus Clinical Investigational Site 9012
Andhra Pradesh,
IndiaSite Not Available
Santarus Clinical Investigational Site 9016
Andhra Pradesh,
IndiaSite Not Available
Santarus Clinical Investigational Site 9006
Assam,
IndiaSite Not Available
Santarus Clinical Investigational Site 9007
Gujarat,
IndiaSite Not Available
Santarus Clinical Investigational Site 9004
Karnataka,
IndiaSite Not Available
Santarus Clinical Investigational Site 9015
Karnataka,
IndiaSite Not Available
Santarus Clinical Investigational Site 9003
Kerala,
IndiaSite Not Available
Santarus Clinical Investigational Site 9002
Maharashtra,
IndiaSite Not Available
Santarus Clinical Investigational Site 9008
Maharashtra,
IndiaSite Not Available
Santarus Clinical Investigational Site 9013
Maharashtra,
IndiaSite Not Available
Santarus Clinical Investigational Site 9018
Rajasthan,
IndiaSite Not Available
Santarus Clinical Investigational Site 9005
Tamil Nadu,
IndiaSite Not Available
Santarus Clinical Investigational Site 9014
Uttar Pradesh,
IndiaSite Not Available
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