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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01046136
Other study ID # 2009-MUC-03
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2009

Study information

Verified date December 2020
Source Reckitt Benckiser LLC
Contact n/a
Is FDA regulated No
Health authority
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. completion date
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

Study Design


Related Conditions & MeSH terms


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
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