Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis (EOS-2)
Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis (EOS-2)
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.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: January 15, 2016
Actual Primary Completion Date: November 28, 2018
Actual Study Completion Date: December 11, 2020
Arm:
- Experimental: Budesonide 0.5mg orodispersible tablet twice daily
- Experimental: Budesonide 1mg orodispersible tablet twice daily
- Placebo Comparator: Placebo orodispersible tablet twice daily
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 204 |
| Actual Study start date | 15 January 2016 |
| Actual Study Completion Date | 11 December 2020 |