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Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection (MCC/CC)

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ClinicalTrials.gov Identifier: NCT01114581
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : October 8, 2012
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acute Respiratory Infection
Interventions Drug: Mucinex
Drug: Placebo
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Guaifenesin Placebo
Hide Arm/Group Description Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets Given as 2 tablets
Period Title: Overall Study
Started 19 19
Completed 19 19
Not Completed 0 0
Arm/Group Title Guaifenesin Placebo Total
Hide Arm/Group Description Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets Given as 2 tablets Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
19
 100.0%
38
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
25.8  (6.0) 30.0  (11.94) 27.9  (9.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
9
  47.4%
10
  52.6%
19
  50.0%
Male
10
  52.6%
9
  47.4%
19
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Hide Description Percentage of inhaled radioactive tracer (Ave180Clear)
Time Frame 3 hours following inhalation of radioactive tracer particles
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Guaifenesin Placebo
Hide Arm/Group Description:
Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Given as 2 tablets
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Percentage of inhaled radioactive tracer
21.4  (99) 23.1  (99)
2.Secondary Outcome
Title Guaifenesin AUC(0-3)
Hide Description [Not Specified]
Time Frame 3 hours following dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guaifenesin Placebo
Hide Arm/Group Description:
Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Given as 2 tablets
Overall Number of Participants Analyzed 19 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
4060
(71%)
3.Secondary Outcome
Title Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.
Hide Description [Not Specified]
Time Frame Within 10 days of developing symptoms associated with a respiratory tract infection
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this secondary outcome cannot be reported as operational issues with the collection and transport of the samples occurred.
Arm/Group Title Guaifenesin Placebo
Hide Arm/Group Description:
Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Given as 2 tablets
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Guaifenesin Placebo
Hide Arm/Group Description Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets Given as 2 tablets
All-Cause Mortality
Guaifenesin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Guaifenesin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Guaifenesin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gail Solomon, Director, Clinical Development
Organization: Reckitt Benckiser Inc.
Phone: 973-404-2752
EMail: gail.solomon@rb.com
Layout table for additonal information
Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01114581    
Other Study ID Numbers: 2010-MUC-01
First Submitted: April 28, 2010
First Posted: May 3, 2010
Results First Submitted: March 15, 2012
Results First Posted: October 8, 2012
Last Update Posted: September 19, 2018