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

This study has been completed.
Sponsor:
Collaborator:
Cosmo Technologies Ltd
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01100112
First received: April 6, 2010
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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]).


Condition Intervention Phase
Colitis, Ulcerative
Drug: Budesonide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • The Percentage of Patients Achieving Clinical Remission [ Time Frame: At the end of the 8 week treatment period ] [ Designated as safety issue: No ]

    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:
  • The Secondary Efficacy Endpoint is Clinical Improvement [ Time Frame: After 8 weeks treatment period ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Endoscopic Improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 61
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide
Budesonide-MMX 9 mg tablet
Drug: Budesonide
One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100112

Locations
India
Santarus Clinical Investigational Site 9001
Andhra Pradesh, India
Santarus Clinical Investigational Site 9012
Andhra Pradesh, India
Santarus Clinical Investigational Site 9009
Andhra Pradesh, India
Santarus Clinical Investigational Site 9016
Andhra Pradesh, 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 9015
Karnataka, India
Santarus Clinical Investigational Site 9003
Kerala, India
Santarus Clinical Investigational Site 9002
Maharashtra, India
Santarus Clinical Investigational Site 9013
Maharashtra, India
Santarus Clinical Investigational Site 9008
Maharashtra, India
Santarus Clinical Investigational Site 9018
Rajasthan, India
Santarus Clinical Investigational Site 9005
Tamil Nadu, India
Santarus Clinical Investigational Site 9014
Uttar Pradesh, India
Sponsors and Collaborators
Salix Pharmaceuticals
Cosmo Technologies Ltd
  More Information

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01100112     History of Changes
Other Study ID Numbers: CB-01-02/06
Study First Received: April 6, 2010
Results First Received: March 28, 2014
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Salix Pharmaceuticals:
ulcerative colitis
Budesonide

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014