drugset / Trial / NCT01744106
A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
Phase 3
Completed
565 enrolled
Perrigo Company
Chattem, Inc. · collabGlaxoSmithKline · collabMcNeil Consumer Healthcare Division of McNEIL-PPC, Inc. · collabPfizer · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is designed to confirm the effectiveness of single-ingredient pseudoephedrine in children for the temporary relief of nasal congestion due to the common cold, an indication described under 21 CFR 341.80(b)(1).
Timeline
- Start
- 2012-11
- Primary completion
- 2016-04
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pseudoephedrine | Small molecule | 30 mg | — |