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Completed

NCT Number: NCT01537081

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

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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Key information

Conditions

Acute Upper Respiratory Tract Infection

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Reckitt Benckiser Study Site, Hoover, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Chronic illnesses.
  • Febrile illness > 101 F within 7 days prior to Day 1,
  • Pregnant.
  • Known current malignancy.

Treatment and study plan

Mucinex

Drug

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

Immediate-release Guaifenesin

Drug

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

Placebo

Drug

Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water

Primary outcomes

  1. Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4

    Time frame: Day 4

    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.

  2. Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5

    Time frame: Day 5

    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.

Sponsors and collaborators

Lead sponsor

Reckitt Benckiser LLC

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 22, 2012
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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