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NCT02493335: EOS-2
Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis
Phase 3 trial testing Budesonide 0.5mg orodispersible tablet twice daily in Eosinophilic Esophagitis in 204 participants. Completed in 11 December 2020.
28 November 2018
Quick facts
| Lead sponsor | Dr. Falk Pharma GmbH |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 204 |
| Start date | 15 January 2016 |
| Primary completion | 28 November 2018 |
| Estimated completion | 11 December 2020 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Budesonide 0.5mg orodispersible tablet twice daily — full drug profile →
- Budesonide 1mg orodispersible tablet twice daily — full drug profile →
- Placebo orodispersible tablet twice daily — full drug profile →
Conditions studied
- Eosinophilic Esophagitis — all drugs for Eosinophilic Esophagitis →
Sponsor
Dr. Falk Pharma GmbH — full company profile →
Who can join
Adults 18 to 75, any sex, with Eosinophilic Esophagitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effectiveness and Safety of High- vs Low-Dose Swallowed Topical Steroids for Maintenance Treatment of Eosinophilic Esophagitis: A Multicenter Observational Study.
Greuter T, Godat A, Ringel A, Almonte HS, et al · · 2021 · cited 35× · PMID 32798703 · DOI 10.1016/j.cgh.2020.08.027 -
Diagnostic and Therapeutic Long-term Management of Eosinophilic Esophagitis- Current Concepts and Perspectives for Steroid Use.
Greuter T, Alexander JA, Straumann A, Katzka DA. · · 2018 · cited 35× · PMID 30802222 · DOI 10.1038/s41424-018-0074-8 -
Medical concept normalization in clinical trials with drug and disease representation learning.
Miftahutdinov Z, Kadurin A, Kudrin R, Tutubalina E. · · 2021 · cited 17× · PMID 34213526 · DOI 10.1093/bioinformatics/btab474 -
Recent discoveries and emerging therapeutics in eosinophilic esophagitis.
Goyal A, Cheng E. · · 2016 · cited 11× · PMID 26855809 · DOI 10.4292/wjgpt.v7.i1.21 -
Efficacy and Safety of Budesonide Orodispersible Tablets for Eosinophilic Esophagitis up to 3 Years: An Open-Label Extension Study.
Biedermann L, Schlag C, Straumann A, Lucendo AJ, et al · · 2025 · cited 8× · PMID 39694205 · DOI 10.1016/j.cgh.2024.10.034 -
Recent advances in eosinophilic esophagitis.
Durrani S, Rothenberg M. · · 2017 · cited 3× · PMID 29043074 · DOI 10.12688/f1000research.11798.1 -
The Therapeutic Pipeline for Eosinophilic Esophagitis: Current Landscape and Future Directions.
Pasta A, Bertin L, Mari A, Calabrese F, et al · · 2025 · cited 1× · PMID 41471371 · DOI 10.3390/ph18121882
Verify or expand the search:
- PubMed search for NCT02493335
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Eosinophilic Esophagitis
Currently open trials in the same condition.
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- NCT06972147 — Prevalence and Description of FIRE (Food Induced Immediate Response of the Esophagus) in the Pediatric Population With E · recruiting
- NCT06695897 — A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patie · recruiting
- NCT06443346 — Prospective Registry of EoSinophilic esOphagitis · recruiting
Other Dr. Falk Pharma GmbH trials
Trials by the same sponsor.
- NCT05488405 — Mesalazine Oral Suspension in Active Eosinophilic Esophagitis · Phase 2 · completed
- NCT05621811 — Different Doses of Naronapride vs. Placebo in Gastroparesis · Phase 2 · completed
- NCT05305599 — Different Doses of ZED1227 vs. Placebo in NAFLD · Phase 2 · completed
- NCT02434029 — Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis · Phase 3 · completed
- NCT02280629 — Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2) · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02493335 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Falk Pharma GmbH
- Last refreshed: 7 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02493335.
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