Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01537081
First received: February 16, 2012
Last updated: October 22, 2013
Last verified: October 2013
Results First Received: July 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Acute Upper Respiratory Tract Infection
Interventions: Drug: Mucinex
Drug: Immediate-release Guaifenesin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
A total of 3215 patients were screened for enrollment, and 405 did not proceed in the study. Participants were randomized in a 2:2:1 ratio.

Reporting Groups
  Description
Mucinex 2400 mg/Day The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
Immediate-release Guaifenesin 800 mg/Day The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
Placebo Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.

Participant Flow:   Overall Study
    Mucinex 2400 mg/Day   Immediate-release Guaifenesin 800 mg/Day   Placebo
STARTED   1123   1124   563 
Safety Population   1122   1122   561 
Modified Intent to Treat Population   1106   1109   556 
COMPLETED   1084   1086   547 
NOT COMPLETED   39   38   16 
Adverse Event                5                2                2 
Lack of Efficacy                2                1                0 
Lost to Follow-up                17                15                9 
Protocol Violation                3                2                2 
Withdrawal by Subject                6                11                3 
Physician Decision                5                6                0 
Sponsor decision                0                1                0 
Assigned but never dosed                1                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Based on the Safety population, defined as all patients who received at least one dose of the study medication, excluding patients who later return all the dispensed study medication to the site unused.

Reporting Groups
  Description
Mucinex 2400 mg/Day The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
Immediate-release Guaifenesin 800 mg/Day The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
Placebo Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
Total Total of all reporting groups

Baseline Measures
   Mucinex 2400 mg/Day   Immediate-release Guaifenesin 800 mg/Day   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1122   1122   561   2805 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.3  (13.81)   36.8  (13.81)   37.9  (14.09)   37.2  (13.87) 
Gender 
[Units: Participants]
       
Female   670   668   333   1671 
Male   452   454   228   1134 
Race/Ethnicity, Customized 
[Units: Participants]
       
American Indian or Alaska Native   1   7   2   10 
Asian   31   25   13   69 
Native Hawaiian or Other Pacific Islander   4   3   3   10 
Black or African American   382   419   200   1001 
White   686   656   327   1669 
Other   18   12   16   46 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4   [ Time Frame: Day 4 ]

2.  Primary:   Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5   [ Time Frame: Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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,MS; Director Clinical Development
Organization: Reckitt Benckiser LLC
phone: 973-404-2752
e-mail: gail.solomon@rb.com



Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01537081     History of Changes
Other Study ID Numbers: 2011-MUC-04
Study First Received: February 16, 2012
Results First Received: July 3, 2013
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration