Back to resultsMucinex Exploratory Cold Study
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
guaifenesin (Mucinex)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring common cold
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
Sites / Locations
- Pioneer Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mucinex
placebo
Arm Description
Outcomes
Primary Outcome Measures
Investigator's End of Study Assessment of Treatment
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.
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
Number of Patients With Adverse Events
Total number of patients with adverse events that were possibly or probably related.
Full Information
NCT ID
NCT01046136
First Posted
January 7, 2010
Last Updated
December 3, 2020
Sponsor
Reckitt Benckiser Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01046136
Brief Title
Mucinex Exploratory Cold Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
common cold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
378 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mucinex
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
guaifenesin (Mucinex)
Intervention Description
bid 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
bid 7 days
Primary Outcome Measure Information:
Title
Investigator's End of Study Assessment of Treatment
Description
Yes the investigator would use this treatment for cold symptoms in the future.
Time Frame
7 days
Title
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.
Description
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.
Time Frame
Baseline and Day 4
Secondary Outcome Measure Information:
Title
Number of Patients With Adverse Events
Description
Total number of patients with adverse events that were possibly or probably related.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Pioneer Clinical Research
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24003241
Citation
Hoffer-Schaefer A, Rozycki HJ, Yopp MA, Rubin BK. Guaifenesin has no effect on sputum volume or sputum properties in adolescents and adults with acute respiratory tract infections. Respir Care. 2014 May;59(5):631-6. doi: 10.4187/respcare.02640. Epub 2013 Sep 3.
Results Reference
derived
PubMed Identifier
23270519
Citation
Albrecht H, Vernon M, Solomon G. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms. Respir Res. 2012 Dec 27;13(1):118. doi: 10.1186/1465-9921-13-118.
Results Reference
derived
Learn more about this trial
Mucinex Exploratory Cold Study
We'll reach out to this number within 24 hrs