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Aminosalicylate

2: budesonide-MMX® 9 mg for Ulcerative Colitis

Phase 3
Waitlist Available
Led By Bruce Eric Sands
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

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.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical and Endoscopic Remission.
Secondary study objectives
Clinical Improvement.
Endoscopic Improvement

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 2: budesonide-MMX® 9 mgExperimental Treatment2 Interventions
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Group II: 1: budesonide-MMX® 6 mgExperimental Treatment2 Interventions
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Group III: 4: Asacol® 400 mgActive Control2 Interventions
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Group IV: 3: PlaceboPlacebo Group2 Interventions
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood sampling, endoscopy
2008
Completed Phase 3
~1030
Budesonide
FDA approved
Budesonide
FDA approved

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,526 Total Patients Enrolled
13 Trials studying Ulcerative Colitis
3,735 Patients Enrolled for Ulcerative Colitis
Bruce Eric SandsPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
123 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
123 Patients Enrolled for Ulcerative Colitis
~29 spots leftby Oct 2025
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