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

NCT01744106 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 565

Last updated 2016-04-22

No results posted yet for this study

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

DRUG

pseudoephedrine hydrochloride 30 mg tablets

DRUG

Placebo tablets

Sponsors & Collaborators

  • McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Chattem, Inc.

    collaborator INDUSTRY

  • Perrigo Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01744106 on ClinicalTrials.gov