Phase 3
N=2,810
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
Acute Upper Respiratory Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01537081 ↗Enrolled (actual)
2,810
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 — 12.96; 12.87; 12.71 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mucinex (Drug); Immediate-release Guaifenesin (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Reckitt Benckiser LLC
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 |
12.96; 12.87; 12.71 | — |
| PRIMARY Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5 |
10.92; 10.80; 11.05 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Has developed cold symptoms within 3 days prior to dosing on Day 1.
Exclusion Criteria
- Chronic illnesses.
- Febrile illness > 101 F within 7 days prior to Day 1,
- Pregnant.
- Known current malignancy.
Data sourced from ClinicalTrials.gov (NCT01537081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.