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

Phase 2

Completed

• Conditions: Acute Upper Respiratory Tract Infection
• Interventions: Drug: Immediate-release Guaifenesin; Drug: Mucinex; Drug: Placebo

• Registration Number: NCT01537081
• Lead Sponsor: Reckitt Benckiser LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Primary Completion: 2012-03
• Study Completion: 2012-07
• Results First Submitted: 2013-07-03
• Results First Submitted QC: 2013-07-03
• Results First Posted: 2013-09-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-22
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2810

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucinex 2400 mg/day	Placebo	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	Placebo	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	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.
Immediate-release Guaifenesin 800 mg/Day	Immediate-release Guaifenesin	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.
Mucinex 2400 mg/day	Mucinex	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.

Primary Outcome Measures

Name	Time	Method
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5	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.
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4	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.

Trial Locations

Locations (1)

Reckitt Benckiser Study Site; 🇺🇸 Spokane, Washington, United States