Phase 2 N=378 Randomized Quadruple-blind Treatment

Mucinex Exploratory Cold Study

Common Cold

Bottom Line

View on ClinicalTrials.gov: NCT01046136 ↗

Enrolled (actual)

378

Serious AEs

0.3%

Results posted

Aug 2012

Primary outcome: Primary: Investigator's End of Study Assessment of Treatment — 163; 149 participants — p=0.0096

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: guaifenesin (Mucinex) (Drug); placebo (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Reckitt Benckiser Inc.
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Investigator's End of Study Assessment of Treatment	163; 149	0.0096 sig
PRIMARY Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.	-1.1; -0.9	0.0293 sig
SECONDARY Number of Patients With Adverse Events	12; 6	—

Summary

This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.

Eligibility Criteria

Inclusion Criteria

common cold symptoms
meet symptom severity
females of child-bearing potential must have negative pregnancy test and use effective birth control

Exclusion Criteria

chronic respiratory conditions
significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder
pregnant or lactating
known malignancy
participation in any other clinical trial within 30 days of baseline
related to another enrolled patient or persons involved directly or indirectly with the conduct of this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01046136). 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.