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Budesonide vs mesalazine vs placebo in collagenous colitis
2006-004159-39Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2006
- Countries
- 1
- Sponsor
- Dr. Falk Pharma GmbH
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Small Molecules
- Drugs
- budesonideSalcrozine
- Conditions
- collagenous colitis (CC)
01
Overview
Phase 3, randomised, double-blind trial in collagenous colitis (CC) comparing Budesonide, Mesalazine and Placebo (3 arms). Primary endpoint: Clinical remission at 8 weeks. Started Dec 2006; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Budesonide
Patients receive oral budesonide 9 mg/day via capsules plus placebo granules in a double-dummy regimen.
Mesalazine
Patients receive oral mesalazine granules 3 g/day plus placebo capsules in a double-dummy regimen.
Placebo
Patients receive placebo capsules and placebo granules matching active treatments.
03
Who it enrols
Adults with histologically confirmed collagenous colitis and active diarrhea (>4 watery or soft stools on at least 4 days in the week before baseline), without evidence of infectious diarrhea. Antidiarrheal medications must be discontinued at least 2 weeks prior to baseline.
04
Endpoints
Primary
Clinical remission at 8 weeks
Secondary
Clinical remission at 2 weeks
Safety and tolerability
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