(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
- Registration Number
- NCT01100112
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Budesonide Budesonide Budesonide-MMX 9 mg tablet
- Primary Outcome Measures
Name Time Method The Percentage of Patients Achieving Clinical Remission At the end of the 8 week treatment period The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of \< or = 1 with a score of 0 for both rectal bleeding and stool frequency, and \> or = 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance).
The UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum \[worst\] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = \> 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding.
- Secondary Outcome Measures
Name Time Method The Secondary Efficacy Endpoint is Clinical Improvement After 8 weeks treatment period The secondary efficacy endpoint is clinical improvement, defined as a drop in the Ulcerative Colitis Disease Activity Index score of \> or = 3 points from baseline.
Endoscopic Improvement 8 weeks Greater or equal to a 1 point improvement in the mucosal appearance subscore of the ulcerative colitis disease activity index (UCDAI), from baseline to week 8.
The UCDAI mucosal appearance subscore is graded as follows: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding.Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study. Throughout the 8 week treatment period Safety will be assessed by evaluating SAEs and AEs. The outcome measure data are the numbers of patients who experienced SAEs or other nonserious AEs.
Trial Locations
- Locations (15)
Santarus Clinical Investigational Site 9015
🇮🇳Karnataka, India
Santarus Clinical Investigational Site 9001
🇮🇳Andhra Pradesh, India
Santarus Clinical Investigational Site 9009
🇮🇳Andhra Pradesh, India
Santarus Clinical Investigational Site 9012
🇮🇳Andhra Pradesh, India
Santarus Clinical Investigational Site 9016
🇮🇳Andhra Pradesh, India
Santarus Clinical Investigational Site 9018
🇮🇳Rajasthan, India
Santarus Clinical Investigational Site 9006
🇮🇳Assam, India
Santarus Clinical Investigational Site 9007
🇮🇳Gujarat, India
Santarus Clinical Investigational Site 9004
🇮🇳Karnataka, India
Santarus Clinical Investigational Site 9005
🇮🇳Tamil Nadu, India
Santarus Clinical Investigational Site 9014
🇮🇳Uttar Pradesh, India
Santarus Clinical Investigational Site 9003
🇮🇳Kerala, India
Santarus Clinical Investigational Site 9002
🇮🇳Maharashtra, India
Santarus Clinical Investigational Site 9008
🇮🇳Maharashtra, India
Santarus Clinical Investigational Site 9013
🇮🇳Maharashtra, India