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Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

NCT01532648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2019-09-06

Study results available
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Summary

This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

Conditions

Interventions

DRUG

Budesonide MMX®

Oral tablet taken daily in the morning after breakfast.

DRUG

Placebo

Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.

DRUG

5-ASA

Acceptable oral 5-ASA medications to be received during the study include: * Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g) * Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g * Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g * Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Lindsey Mathew · Bausch Health Companies

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
2012-01-27
Primary Completion
2013-10-02
Completion
2013-10-02

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Russia
  • Ukraine

Study Locations

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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 NCT01532648 on ClinicalTrials.gov