Mucinex Exploratory Cold Study

Phase 2

Completed

• Conditions: Common Cold
• Interventions: Drug: placebo; Drug: guaifenesin (Mucinex)

• Registration Number: NCT01046136
• Lead Sponsor: Reckitt Benckiser Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2010-03
• Results First Submitted: 2011-03-03
• Results First Submitted QC: 2012-08-23
• Results First Posted: 2012-08-24
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
Mucinex	guaifenesin (Mucinex)	-

Primary Outcome Measures

Name	Time	Method
Investigator's End of Study Assessment of Treatment	7 days	Yes the investigator would use this treatment for cold symptoms in the future.
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.	Baseline and Day 4	Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events	7 days	Total number of patients with adverse events that were possibly or probably related.

Trial Locations

Locations (1)

Pioneer Clinical Research; 🇺🇸 Bellevue, Nebraska, United States