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

NCT ID: NCT01537081

Last Updated: 2013-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Acute Upper Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Mucinex

Intervention Type 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.

Placebo

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Immediate-release Guaifenesin

Intervention Type DRUG

Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.

Placebo

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Immediate-release Guaifenesin

Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Mucinex® guaifenesin IR guaifenesin IR GGE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reckitt Benckiser LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Reckitt Benckiser Study Site

Hoover, Alabama, United States

Site Status

Reckitt Benckiser Study Site

Bell Gardens, California, United States

Site Status

Reckitt Benckiser Study Site

Harbor City, California, United States

Site Status

Reckitt Benckiser Study Site

Long Beach, California, United States

Site Status

Reckitt Benckiser Study Site

Sacramento, California, United States

Site Status

Reckitt Benckiser Study Site

San Francisco, California, United States

Site Status

Reckitt Benckiser Study Site

San Luis Obispo, California, United States

Site Status

Reckitt Benckiser Study Site

Colorado Springs, Colorado, United States

Site Status

Reckitt Benckiser Study Site

Denver, Colorado, United States

Site Status

Reckitt Benckiser Study Site

Daytona Beach, Florida, United States

Site Status

Reckitt Benckiser Study Site

Edgewater, Florida, United States

Site Status

Reckitt Benckiser Study Site

Largo, Florida, United States

Site Status

Reckitt Benckiser Study Site

Chicago, Illinois, United States

Site Status

Reckitt Benckiser Study Site

Normal, Illinois, United States

Site Status

Reckitt Benckiser Study Site

Wichita, Kansas, United States

Site Status

Reckitt Benckiser Study Site

Lexington, Kentucky, United States

Site Status

Reckitt Benckiser Study Site

Metairie, Louisiana, United States

Site Status

Reckitt Benckiser Study Site

New Orleans, Louisiana, United States

Site Status

Reckitt Benckiser Study Site

Brighton, Massachusetts, United States

Site Status

Reckitt Benckiser Study Site

Fall River, Massachusetts, United States

Site Status

Reckitt Benckiser Study Site

Bellevue, Nebraska, United States

Site Status

Reckitt Benckiser Study Site

Omaha, Nebraska, United States

Site Status

Reckitt Benckiser Study Site

Omaha, Nebraska, United States

Site Status

Reckitt Benckiser Study Site

Las Vegas, Nevada, United States

Site Status

Reckitt Benckiser Study Site

Las Vegas, Nevada, United States

Site Status

Reckitt Benckiser Study Site

Rochester, New York, United States

Site Status

Reckitt Benckiser Study Site

Raleigh, North Carolina, United States

Site Status

Reckitt Benckiser Study Site

Cincinnati, Ohio, United States

Site Status

Reckitt Benckiser Study Site

Middleburg Heights, Ohio, United States

Site Status

Reckitt Benckiser Study Site

Warwick, Rhode Island, United States

Site Status

Reckitt Benckiser Study Site

Greer, South Carolina, United States

Site Status

Reckitt Benckiser Study Site

Dakota Dunes, South Dakota, United States

Site Status

Reckitt Benckiser Study Site

Franklin, Tennessee, United States

Site Status

Reckitt Benckiser Study Site

Jackson, Tennessee, United States

Site Status

Reckitt Benckiser Study Site

New Tazewell, Tennessee, United States

Site Status

Reckitt Benckiser Study Site

Smyrna, Tennessee, United States

Site Status

Reckitt Benckiser Study Site

Austin, Texas, United States

Site Status

Reckitt Benckiser Study Site

Carrollton, Texas, United States

Site Status

Reckitt Benckiser Study Site

Forth Worth, Texas, United States

Site Status

Reckitt Benckiser Study Site

San Angelo, Texas, United States

Site Status

Reckitt Benckiser Study Site

Tomball, Texas, United States

Site Status

Reckitt Benckiser Study Site

Salt Lake City, Utah, United States

Site Status

Reckitt Benckiser Study Site

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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2011-MUC-04

Identifier Type: -

Identifier Source: org_study_id