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(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

NCT00679432 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2019-12-10

Study results available
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Summary

The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.

Conditions

Interventions

PROCEDURE

Blood sampling, endoscopy

Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores

DRUG

budesonide-MMX® 6 mg

6 mg/day, 6 mg tablets

DRUG

budesonide-MMX® 9 mg

9 mg/day, 9 mg tablets

DRUG

Placebo

Placebo

DRUG

Asacol® 400 mg

2400 mg/day, 400 mg tablets

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce Eric Sands · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • United States
  • Canada
  • India
  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00679432 on ClinicalTrials.gov