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

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Budesonide
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring ulcerative colitis, Budesonide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santarus Clinical Investigational Site 9001
  • Santarus Clinical Investigational Site 9009
  • Santarus Clinical Investigational Site 9012
  • Santarus Clinical Investigational Site 9016
  • Santarus Clinical Investigational Site 9006
  • Santarus Clinical Investigational Site 9007
  • Santarus Clinical Investigational Site 9004
  • Santarus Clinical Investigational Site 9015
  • Santarus Clinical Investigational Site 9003
  • Santarus Clinical Investigational Site 9002
  • Santarus Clinical Investigational Site 9008
  • Santarus Clinical Investigational Site 9013
  • Santarus Clinical Investigational Site 9018
  • Santarus Clinical Investigational Site 9005
  • Santarus Clinical Investigational Site 9014

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Budesonide

Arm Description

Budesonide-MMX 9 mg tablet

Outcomes

Primary Outcome Measures

The Percentage of Patients Achieving Clinical Remission
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
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.
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
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.

Full Information

First Posted
April 6, 2010
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
Collaborators
Cosmo Technologies Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01100112
Brief Title
(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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Cosmo Technologies Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
ulcerative colitis, Budesonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide
Arm Type
Experimental
Arm Description
Budesonide-MMX 9 mg tablet
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
Primary Outcome Measure Information:
Title
The Percentage of Patients Achieving Clinical Remission
Description
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.
Time Frame
At the end of the 8 week treatment period
Secondary Outcome Measure Information:
Title
The Secondary Efficacy Endpoint is Clinical Improvement
Description
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.
Time Frame
After 8 weeks treatment period
Title
Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.
Description
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.
Time Frame
Throughout the 8 week treatment period
Title
Endoscopic Improvement
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Santarus Clinical Investigational Site 9001
City
Andhra Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 9009
City
Andhra Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 9012
City
Andhra Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 9016
City
Andhra Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 9006
City
Assam
Country
India
Facility Name
Santarus Clinical Investigational Site 9007
City
Gujarat
Country
India
Facility Name
Santarus Clinical Investigational Site 9004
City
Karnataka
Country
India
Facility Name
Santarus Clinical Investigational Site 9015
City
Karnataka
Country
India
Facility Name
Santarus Clinical Investigational Site 9003
City
Kerala
Country
India
Facility Name
Santarus Clinical Investigational Site 9002
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9008
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9013
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9018
City
Rajasthan
Country
India
Facility Name
Santarus Clinical Investigational Site 9005
City
Tamil Nadu
Country
India
Facility Name
Santarus Clinical Investigational Site 9014
City
Uttar Pradesh
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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