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NCT01919554
Investigation of the Safety and Tolerability of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents With House Dust Mite-associated Allergic Rhinitis
Phase 1 trial testing 500 IR house dust mites allergen extract tablet in Allergic Rhinitis Due to House Dust Mite in 37 participants. Completed in 1 September 2013.
1 September 2013
Quick facts
| Lead sponsor | Stallergenes Greer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 1 July 2013 |
| Primary completion | 1 September 2013 |
| Estimated completion | 1 September 2013 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- 500 IR house dust mites allergen extract tablet — full drug profile →
- 1000 IR house dust mites allergen extract tablet — full drug profile →
- 1500 IR house dust mites allergen extract tablet — full drug profile →
- Placebo tablet
Conditions studied
- Allergic Rhinitis Due to House Dust Mite — all drugs for Allergic Rhinitis Due to House Dust Mite →
Sponsor
Stallergenes Greer — full company profile →
Who can join
Adults 12 to 17, any sex, with Allergic Rhinitis Due to House Dust Mite. 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.
-
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
Time frame: 10 dosing treatment days
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
Sponsor's own description
The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.
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 NCT01919554
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Allergic Rhinitis Due to House Dust Mite
Currently open trials in the same condition.
- NCT07452380 — The Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatr · recruiting
Other Stallergenes Greer trials
Trials by the same sponsor.
- NCT05668390 — Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma · Phase 3 · completed
- NCT06574061 — Evaluation of the Benefits of Sublingual AIT (PRACTIS) · completed
- NCT02443805 — Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR · Phase 3 · completed
- NCT04004351 — Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma · 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 NCT01919554 (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 Stallergenes Greer
- Last refreshed: 27 November 2024
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/NCT01919554.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing