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
  Purpose

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.


Condition Intervention Phase
Acute Upper Respiratory Tract Infection
Drug: Mucinex
Drug: Immediate-release Guaifenesin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • 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.


Enrollment: 2810
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: Placebo
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
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.
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
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.
Drug: Placebo
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537081

  Show 43 Study Locations
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

No publications provided

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

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014