Overview

A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Perrigo Company
Collaborators:
Chattem, Inc.
GlaxoSmithKline
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Pfizer
Treatments:
Ephedrine
Pseudoephedrine