NCT01744106

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

A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 565 (actual)
• Sponsor: Perrigo Company · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Nasal Congestion Associated With the Common Cold

Interventions

Type	Name	Description
DRUG	pseudoephedrine hydrochloride 30 mg tablets
DRUG	Placebo tablets

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-12-06
• Last updated: 2016-04-22

Locations

11 sites across 1 country: United States