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NCT01368445
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Patients With Seasonal Allergic Rhinitis
Phase 3 trial testing azelastine hydrochloride 0.15% Nasal Spray in Seasonal Allergic Rhinitis in 617 participants. Completed in 1 April 2008.
1 November 2006
Quick facts
| Lead sponsor | Meda Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 617 |
| Start date | 1 August 2006 |
| Primary completion | 1 November 2006 |
| Estimated completion | 1 April 2008 |
| Sites | 30 locations across United States |
Drugs / interventions tested
- azelastine hydrochloride 0.15% Nasal Spray — full drug profile →
- azelastine hydrochloride 0.15% and Placebo — full drug profile →
- Azelastine 0.1%, Nasal Spray — full drug profile →
Conditions studied
- Seasonal Allergic Rhinitis — all drugs for Seasonal Allergic Rhinitis →
Sponsor
Meda Pharmaceuticals — full company profile →
Who can join
12 and older, any sex, with Seasonal Allergic Rhinitis. 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.
-
Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo
Time frame: 14 Days
Sponsor's own description
The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal 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 NCT01368445
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Seasonal Allergic Rhinitis
Currently open trials in the same condition.
- NCT07055542 — Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study · NA · recruiting
- NCT06846385 — Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic · Phase 2, PHASE3 · recruiting
- NCT07291284 — Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis · Phase 3 · active not recruiting
- NCT06300203 — Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis · Phase 2 · recruiting
- NCT04815668 — Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis · NA · recruiting
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 NCT01368445 (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 Meda Pharmaceuticals
- Last refreshed: 5 October 2011
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/NCT01368445.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing