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

This study has been completed.
Sponsor:
Information provided by:
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01114581
First received: April 28, 2010
Last updated: September 7, 2012
Last verified: September 2012
Results First Received: March 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Acute Respiratory Infection
Interventions: Drug: Mucinex
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Guaifenesin Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Placebo Given as 2 tablets

Participant Flow:   Overall Study
    Guaifenesin     Placebo  
STARTED     19     19  
COMPLETED     19     19  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Guaifenesin Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Placebo Given as 2 tablets
Total Total of all reporting groups

Baseline Measures
    Guaifenesin     Placebo     Total  
Number of Participants  
[units: participants]
  19     19     38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     19     38  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  25.8  ± 6.0     30.0  ± 11.94     27.9  ± 9.56  
Gender  
[units: participants]
     
Female     9     10     19  
Male     10     9     19  
Region of Enrollment  
[units: participants]
     
United States     19     19     38  



  Outcome Measures
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1.  Primary:   Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs   [ Time Frame: 3 hours following inhalation of radioactive tracer particles ]

2.  Secondary:   Guaifenesin AUC(0-3)   [ Time Frame: 3 hours following dose administration ]

3.  Secondary:   Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.   [ Time Frame: Within 10 days of developing symptoms associated with a respiratory tract infection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gail Solomon, Director, Clinical Development
Organization: Reckitt Benckiser Inc.
phone: 973-404-2752
e-mail: gail.solomon@rb.com


No publications provided


Responsible Party: William Bennett, PhD, UNC at Chapel Hill
ClinicalTrials.gov Identifier: NCT01114581     History of Changes
Other Study ID Numbers: 2010-MUC-01
Study First Received: April 28, 2010
Results First Received: March 15, 2012
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration