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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

February 16, 2012
October 22, 2013
September 2011
March 2012   (final data collection date for primary outcome measure)
  • Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
  • Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
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Complete list of historical versions of study NCT01537081 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d) in the Treatment of Symptoms of Acute Upper Respiratory Tract Infections For 7 Days

The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.

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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Upper Respiratory Tract Infection
  • Drug: Mucinex
    Mucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet. Each tablet was 600 mg of guaifenesin and taken by mouth with a full glass of water.
    Other Names:
    • Mucinex®
    • guaifenesin
  • Drug: Immediate-release Guaifenesin
    Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
    Other Names:
    • IR guaifenesin
    • IR GGE
  • Drug: Placebo
    Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
  • Experimental: 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.
    Interventions:
    • Drug: Mucinex
    • Drug: Placebo
  • Active Comparator: 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.
    Interventions:
    • Drug: Immediate-release Guaifenesin
    • Drug: Placebo
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2810
July 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

1. Has developed cold symptoms within 3 days prior to dosing on Day 1.

Exclusion Criteria:

  1. Chronic illnesses.
  2. Febrile illness > 101 F within 7 days prior to Day 1,
  3. Pregnant.
  4. Known current malignancy.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01537081
2011-MUC-04
No
Reckitt Benckiser LLC
Reckitt Benckiser LLC
Not Provided
Not Provided
Reckitt Benckiser LLC
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP