Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reckitt Benckiser LLC
• Treatments: Chlorpheniramine, phenylpropanolamine drug combination; Guaifenesin; Phenylpropanolamine

Criteria

Inclusion Criteria:

1. Has developed cold symptoms within 3 days prior to dosing on Day 1.

Exclusion Criteria:

1. Chronic illnesses.

2. Febrile illness > 101 F within 7 days prior to Day 1,

3. Pregnant.

4. Known current malignancy.