Trials / Completed
CompletedNCT02493335
Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis
Double-blind, Randomized, Placebo-controlled, Phase III Study on the Efficacy and Tolerability of a 48-week Treatment With Two Different Doses of Budesonide Effervescent Tablets vs. Placebo for Maintenance of Clinico-pathological Remission in Adult Patients With Eosinophilic Esophagitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 204 (actual)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Budesonide 0.5mg orodispersible tablet twice daily | |
| DRUG | Budesonide 1mg orodispersible tablet twice daily | |
| DRUG | Placebo orodispersible tablet twice daily |
Timeline
- Start date
- 2016-01-15
- Primary completion
- 2018-11-28
- Completion
- 2020-12-11
- First posted
- 2015-07-09
- Last updated
- 2021-10-07
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02493335. Inclusion in this directory is not an endorsement.