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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Common Cold
  • Nasal Congestion Associated With the Common Cold

NCT number NCT01744106
Study type Interventional
Source Perrigo Company
Contact
Status Recruiting
Phase Phase 3
Start date November 2012
Completion date May 2016