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NCT02849210
A Phase I Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea
Phase 1 trial testing Allergovac depot with Olea europaea pollen extract in Rhinoconjunctivitis in 47 participants. Completed in 2 June 2017.
2 June 2017
Quick facts
| Lead sponsor | Roxall Medicina España S.A |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 1 September 2015 |
| Primary completion | 2 June 2017 |
| Estimated completion | 2 June 2017 |
| Sites | 5 locations across Spain |
Drugs / interventions tested
- Allergovac depot with Olea europaea pollen extract — full drug profile →
Conditions studied
- Rhinoconjunctivitis — all drugs for Rhinoconjunctivitis →
Sponsor
Roxall Medicina España S.A — full company profile →
Who can join
Adults 18 to 65, any sex, with Rhinoconjunctivitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number and severity of adverse reactions as a measure of Safety and tolerability
Time frame: 17 weeks treatment period
Sponsor's own description
The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Olea europaea pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02849210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Roxall Medicina España S.A trials
Trials by the same sponsor.
- NCT03821077 — Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhi · completed
- NCT02844842 — Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhin · 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 NCT02849210 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Roxall Medicina España S.A
- Last refreshed: 20 October 2017
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/NCT02849210.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing