- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01100112
(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Andhra Pradesh, India
- Santarus Clinical Investigational Site 9001
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Andhra Pradesh, India
- Santarus Clinical Investigational Site 9009
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Andhra Pradesh, India
- Santarus Clinical Investigational Site 9012
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Andhra Pradesh, India
- Santarus Clinical Investigational Site 9016
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Assam, India
- Santarus Clinical Investigational Site 9006
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Gujarat, India
- Santarus Clinical Investigational Site 9007
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Karnataka, India
- Santarus Clinical Investigational Site 9004
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Karnataka, India
- Santarus Clinical Investigational Site 9015
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Kerala, India
- Santarus Clinical Investigational Site 9003
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Maharashtra, India
- Santarus Clinical Investigational Site 9002
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Maharashtra, India
- Santarus Clinical Investigational Site 9008
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Maharashtra, India
- Santarus Clinical Investigational Site 9013
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Rajasthan, India
- Santarus Clinical Investigational Site 9018
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Tamil Nadu, India
- Santarus Clinical Investigational Site 9005
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Uttar Pradesh, India
- Santarus Clinical Investigational Site 9014
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Budesonide
Budesonide-MMX 9 mg tablet
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One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Percentage of Patients Achieving Clinical Remission
Time Frame: At the end of the 8 week treatment period
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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. |
At the end of the 8 week treatment period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Secondary Efficacy Endpoint is Clinical Improvement
Time Frame: After 8 weeks treatment period
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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.
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After 8 weeks treatment period
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Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.
Time Frame: Throughout the 8 week treatment period
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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.
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Throughout the 8 week treatment period
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Endoscopic Improvement
Time Frame: 8 weeks
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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. |
8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
Other Study ID Numbers
- CB-01-02/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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