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NCT01054352
A Double-blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics and Pharmacodynamics of JNJ-38224342 in Healthy Patients and in Healthy Patients With Seasonal Allergic Rhinitis
Phase 1 trial testing JNJ38224342 in Seasonal Allergic Rhinitis in 182 participants. Completed in 1 March 2011.
Quick facts
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 182 |
| Start date | 1 February 2010 |
| Estimated completion | 1 March 2011 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- JNJ38224342 — full drug profile →
- JNJ38224342/placebo — full drug profile →
- JNJ38224342/placebo — full drug profile →
- JNJ38224342/placebo — full drug profile →
Conditions studied
- Seasonal Allergic Rhinitis — all drugs for Seasonal Allergic Rhinitis →
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. — full company profile →
Who can join
Adults 18 to 55, any sex, with Seasonal Allergic Rhinitis. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To assess safety and pharmacokinetics of single and multiple oral ascending doses of JNJ-38224342 with and without food in healthy volunteers and patients with seasonal allergies as determined by occurrence of adverse events, lab test results, vital sign
Time frame: from the time of the first dose to 7-11 days after the last dose administered
Sponsor's own description
A single and multiple dose study to assess the safety of JNJ 38224342 compared to placebo in healthy volunteers and in volunteers with seasonal allergies.
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 NCT01054352
- 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
Other Johnson & Johnson Pharmaceutical Research & Development, L.L.C. trials
Trials by the same sponsor.
- NCT04330248 — A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants · Phase 1 · completed
- NCT01094262 — A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthrit · Phase 2 · terminated
- NCT01060254 — A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain · Phase 2 · terminated
- NCT00973141 — A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis · Phase 2 · terminated
- NCT01756404 — Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy · Phase 1 · 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 NCT01054352 (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 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Last refreshed: 3 September 2013
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/NCT01054352.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing