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

NCT01100112 | Completed Phase 3 Results

• 1 other identifier: CB-01-02/06
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 15

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 \[NCT00679432\]).

Conditions

Colitis, Ulcerative

Keywords

ulcerative colitis; Budesonide

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of the 8 week treatment period

Secondary Outcomes (3)

• The Secondary Efficacy Endpoint is Clinical Improvement

  After 8 weeks treatment period

• 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

• Endoscopic Improvement

  8 weeks

Study Arms (1)

Budesonide

EXPERIMENTAL

Budesonide-MMX 9 mg tablet

Drug: Budesonide

Interventions

Budesonide DRUG

One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.

Budesonide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Cosmo Technologies Ltd: collaborator

Study Sites (15)

Santarus Clinical Investigational Site 9001

Andhra Pradesh, India

Location

Santarus Clinical Investigational Site 9009

Andhra Pradesh, India

Location

Santarus Clinical Investigational Site 9012

Andhra Pradesh, India

Location

Santarus Clinical Investigational Site 9016

Andhra Pradesh, India

Location

Santarus Clinical Investigational Site 9006

Assam, India

Location

Santarus Clinical Investigational Site 9007

Gujarat, India

Location

Santarus Clinical Investigational Site 9004

Karnataka, India

Location

Santarus Clinical Investigational Site 9015

Karnataka, India

Location

Santarus Clinical Investigational Site 9003

Kerala, India

Location

Santarus Clinical Investigational Site 9002

Maharashtra, India

Location

Santarus Clinical Investigational Site 9008

Maharashtra, India

Location

Santarus Clinical Investigational Site 9013

Maharashtra, India

Location

Santarus Clinical Investigational Site 9018

Rajasthan, India

Location

Santarus Clinical Investigational Site 9005

Tamil Nadu, India

Location

Santarus Clinical Investigational Site 9014

Uttar Pradesh, India

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

This was an open label study. There was no reference therapy for statistical analysis.

Results Point of Contact

• Title: Michael Huang, MD, Senior Medical Director, Clinical Research
• Organization: Santarus, Inc.

contact@santarus.com

8583145700

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 29, 2019
• Results First Posted: June 5, 2014

Record last verified: 2019-11

Locations

IN (15)