(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.

NCT00801723 | Completed Phase 3 Results

• 1 other identifier: CB-01-02/04
• Study Type: interventional
• Target: 123
• Locations: 2 countries
• Sites: 58

Brief Summary

Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of treatment. Patients in remission at the End of Study visit will be given the opportunity to enter the 12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will be no interruption of study treatment between the parent studies and this study. It is planned that approximately 150 patients will be enrolled in the study. Patients will be randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI items). During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1, 3, 6, 9, and 12 months of treatment. Patients will be contacted by telephone on a monthly basis for safety assessment. In case of occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled visit at any time during the study.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Clinical Remission

  Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.

  1, 3, 6, 9, and 12 months

Secondary Outcomes (2)

• Percentage of Participants With Clinical Relapse

  12 months

• Percentage of Participants With Endoscopic Relapse

  12 months

Study Arms (2)

1: Budesonide MMX® 6 mg

EXPERIMENTAL

One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.

Drug: Budesonide MMX 6 mg Tablet

2: Placebo

PLACEBO COMPARATOR

One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.

Drug: Placebo Tablet

Interventions

Budesonide MMX 6 mg Tablet DRUG

Budesonide MMX 6 mg Tablet once daily.

1: Budesonide MMX® 6 mg

Placebo Tablet DRUG

Placebo Tablet once daily.

2: Placebo

Eligibility Criteria

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

You may qualify if:

• Patients fulfilling the following criteria are eligible for participation in the study:
• Male and female patients, 18-75 years old, who are able to understand and voluntarily provide written informed consent.
• Patients in UCDAI remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and a ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance).
• Patients who have completed all End of Study assessments for the CB-01-02/01, CB-01-02/02 and CB-01-02/06 studies.
• Females of child-bearing potential must have had a serum pregnancy test performed at the End of Study visit of the parent studies and must use an acceptable contraceptive method throughout the study treatment period.

You may not qualify if:

• Patients who meet any of the following criteria at screening visit are to be excluded from study participation:
• Subjects who have withdrawn from studies CB-01-02/01, CB 01 02/02 or CB-01-02/06.
• Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01, CB 01 02/02 or CB-01-02/06 (i.e. clinical remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability \[score 0 for mucosal appearance\]).
• Subjects with bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (58)

Santarus Clinical Investigational Site 5051

Huntsville, Alabama, 35801, United States

Location

Santarus Clinical Investigational Site 5088

Tucson, Arizona, 85712, United States

Location

Santarus Clinical Investigational Site 5044

Anaheim, California, 92801, United States

Location

Santarus Clinical Investigational Site 5087

Lakewood, California, 90712, United States

Location

Santarus Clinical Investigational Site 5033

Los Angeles, California, 90045, United States

Location

Santarus Clinical Investigational Site 5070

Palm Springs, California, 92262, United States

Location

Santarus Clinical Investigational Site 5067

San Diego, California, 92101, United States

Location

Santarus Clinical Investigational Site 5064

Lakewood, Colorado, 80215, United States

Location

Santarus Clinical Investigational Site 5089

Boynton Beach, Florida, 33426, United States

Location

Santarus Clinical Investigational Site 5041

Hollywood, Florida, 33021, United States

Location

Santarus Clinical Investigational Site 5055

New Smyrna Beach, Florida, 32168, United States

Location

Santarus Clinical Investigational Site 5074

Port Orange, Florida, 32127, United States

Location

Santarus Clinical Investigational Site 5032

Tampa, Florida, 33607, United States

Location

Santarus Clinical Investigational Site 5009

Tampa, Florida, 33613, United States

Location

Santarus Clinical Investigational Site 5047

Winter Park, Florida, 32789, United States

Location

Santarus Clinical Investigational Site 5003

Zephyrhills, Florida, 33542, United States

Location

Santarus Clinical Investigational Site 5016

Atlanta, Georgia, 30312, United States

Location

Santarus Clinical Investigational Site 5056

Columbus, Georgia, 31904, United States

Location

Santarus Clinical Investigational Site 5068

Evanston, Illinois, 60201, United States

Location

Santarus Clinical Investigational Site 5008

Metairie, Louisiana, 70006, United States

Location

Santarus Clinical Investigational Site 5090

Annapolis, Maryland, 21401, United States

Location

Santarus Clinical Investigational Site 5025

Baltimore, Maryland, 21229, United States

Location

Santarus Clinical Investigational Site 5092

Hollywood, Maryland, 20636, United States

Location

Santarus Clinical Investigational Site 5077

Prince Frederick, Maryland, 20678, United States

Location

Santarus Clinical Investigational Site 5010

Chesterfield, Michigan, 48047, United States

Location

Santarus Clinical Investigational Site 5006

Troy, Michigan, 48098, United States

Location

Santarus Clinical Investigational Site 5004

Wyoming, Michigan, 49519, United States

Location

Santarus Clinical Investigational Site 5005

Marlton, New Jersey, 08053, United States

Location

Santarus Clinical Investigational Site 5011

Great Neck, New York, 11021, United States

Location

Santarus Clinical Investigational Site 5101

New York, New York, 10016, United States

Location

Santarus Clinical Investigational Site 5020

Pittsford, New York, 14534, United States

Location

Santarus Clinical Investigational Site 5096

Fayetteville, North Carolina, 28304, United States

Location

Santarus Clinical Investigational Site 5058

Huntersville, North Carolina, 28078, United States

Location

Santarus Clinical Investigational Site 5091

New Bern, North Carolina, 28562, United States

Location

Santarus Clinical Investigational Site 5045

Cincinnati, Ohio, 45219, United States

Location

Santarus Clinical Investigational Site 5078

Dayton, Ohio, 45440, United States

Location

Santarus Clinical Investigational Site 5001

Yukon, Oklahoma, 73099, United States

Location

Santarus Clinical Investigational Site 5066

Duncansville, Pennsylvania, 16635, United States

Location

Santarus Clinical Investigational Site 5065

Pottstown, Pennsylvania, 19464, United States

Location

Santarus Clinical Investigational Site 5035

Sayre, Pennsylvania, 18840, United States

Location

Santarus Clinical Investigational Site 5021

Austin, Texas, 78745, United States

Location

Santarus Clinical Investigational Site 5076

Houston, Texas, 77034, United States

Location

Santarus Clinical Investigational Site 5019

Houston, Texas, 77090, United States

Location

Santarus Clinical Investigational Site 5036

Houston, Texas, 77090, United States

Location

Santarus Clinical Investigational Site 5063

Irving, Texas, 75061, United States

Location

Santarus Clinical Investigational Site 5072

Kingwood, Texas, 77339, United States

Location

Santarus Clinical Investigational Site 5054

La Porte, Texas, 77571, United States

Location

Santarus Clinical Investigational Site 5030

Lewisville, Texas, 75057, United States

Location

Santarus Clinical Investigational Site 5093

Plano, Texas, 75075, United States

Location

Santarus Clinical Investigational Site 5100

San Antonio, Texas, 78229, United States

Location

Santarus Clinical Investigational Site 5079

San Antonio, Texas, 78258, United States

Location

Santarus Clinical Investigational Site 5015

Salt Lake City, Utah, 84107, United States

Location

Santarus Clinical Investigational Site 5097

Christiansburg, Virginia, 24073, United States

Location

Santarus Clinical Investigational Site 6014

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Santarus Clinical Investigational Site 6008

Victoria, British Columbia, V8R 1J8, Canada

Location

Santarus Clinical Investigational Site 6004

Richmond Hill, Ontario, L4B 3P8, Canada

Location

Santarus Clinical Investigational Site 6006

Toronto, Ontario, M3N 2V7, Canada

Location

Santarus Clinical Investigational Site 6013

Longueuil, Quebec, J4N 1E1, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

Study Officials

• Bruce Eric Sands

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Simon Travis

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 31, 2020
• Results First Posted: August 17, 2020

Record last verified: 2020-08

Locations

CA (5); US (53)