Mucinex Exploratory Cold Study

Common Cold Clinical Trial

Official title:

Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046136
• Other study ID #: 2009-MUC-03
• Status: Completed
• Phase: Phase 2
• Start date: December 2009

Study information

• Verified date: December 2020
• Source: Reckitt Benckiser LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• guaifenesin (Mucinex)
bid 7 days
• placebo
bid 7 days

Locations

Country	Name	City	State
United States	Pioneer Clinical Research	Bellevue	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Reckitt Benckiser Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's End of Study Assessment of Treatment	Yes the investigator would use this treatment for cold symptoms in the future.	7 days
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.	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.	Baseline and Day 4
Secondary	Number of Patients With Adverse Events	Total number of patients with adverse events that were possibly or probably related.	7 days