Clinical trial NCT01100112: (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
Official title: Multicenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Keywords: ulcerative colitis
Budesonide
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cosmo Technologies Ltd
First posted: 2010-04-08
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 \[NCT00679432\]).

Detailed 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.

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

Primary outcomes:
measure: The Percentage of Patients Achieving Clinical Remission
timeFrame: At the end of the 8 week treatment period
Secondary outcomes:
measure: The Secondary Efficacy Endpoint is Clinical Improvement
timeFrame: After 8 weeks treatment period
measure: Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.
timeFrame: Throughout the 8 week treatment period
measure: Endoscopic Improvement
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Andhra Pradesh
country: India
facility: Santarus Clinical Investigational Site 9001
city: Andhra Pradesh
country: India
facility: Santarus Clinical Investigational Site 9009
city: Andhra Pradesh
country: India
facility: Santarus Clinical Investigational Site 9012
city: Andhra Pradesh
country: India
facility: Santarus Clinical Investigational Site 9016
city: Assam
country: India
facility: Santarus Clinical Investigational Site 9006
city: Gujarat
country: India
facility: Santarus Clinical Investigational Site 9007
city: Karnataka
country: India
facility: Santarus Clinical Investigational Site 9004
city: Karnataka
country: India
facility: Santarus Clinical Investigational Site 9015
city: Kerala
country: India
facility: Santarus Clinical Investigational Site 9003
city: Maharashtra
country: India
facility: Santarus Clinical Investigational Site 9002
city: Maharashtra
country: India
facility: Santarus Clinical Investigational Site 9008
city: Maharashtra
country: India
facility: Santarus Clinical Investigational Site 9013
city: Rajasthan
country: India
facility: Santarus Clinical Investigational Site 9018
city: Tamil Nadu
country: India
facility: Santarus Clinical Investigational Site 9005
city: Uttar Pradesh
country: India
facility: Santarus Clinical Investigational Site 9014
Study officials:
References: