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

Information source: Reckitt Benckiser LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Upper Respiratory Tract Infection

Intervention: Mucinex (Drug); Immediate-release Guaifenesin (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Reckitt Benckiser LLC

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.

Clinical Details

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

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

Primary outcome:

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

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

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Reckitt Benckiser Study Site, Hoover, Alabama 35216, United States

Reckitt Benckiser Study Site, Bell Gardens, California 90201, United States

Reckitt Benckiser Study Site, Harbor City, California 90710, United States

Reckitt Benckiser Study Site, Long Beach, California 90813, United States

Reckitt Benckiser Study Site, Sacramento, California 95816, United States

Reckitt Benckiser Study Site, San Francisco, California 94102, United States

Reckitt Benckiser Study Site, San Luis Obispo, California 93405, United States

Reckitt Benckiser Study Site, Colorado Springs, Colorado 80907, United States

Reckitt Benckiser Study Site, Denver, Colorado 80239, United States

Reckitt Benckiser Study Site, Daytona Beach, Florida 32117, United States

Reckitt Benckiser Study Site, Edgewater, Florida 32132, United States

Reckitt Benckiser Study Site, Largo, Florida 33710, United States

Reckitt Benckiser Study Site, Chicago, Illinois 60624, United States

Reckitt Benckiser Study Site, Normal, Illinois 61761, United States

Reckitt Benckiser Study Site, Wichita, Kansas 67207, United States

Reckitt Benckiser Study Site, Lexington, Kentucky 40509, United States

Reckitt Benckiser Study Site, Metairie, Louisiana 70006, United States

Reckitt Benckiser Study Site, New Orleans, Louisiana 70115, United States

Reckitt Benckiser Study Site, Brighton, Massachusetts 02135, United States

Reckitt Benckiser Study Site, Fall River, Massachusetts 02720, United States

Reckitt Benckiser Study Site, Bellevue, Nebraska 68005, United States

Reckitt Benckiser Study Site, Omaha, Nebraska 68114, United States

Reckitt Benckiser Study Site, Omaha, Nebraska 68134, United States

Reckitt Benckiser Study Site, Las Vegas, Nevada 89119, United States

Reckitt Benckiser Study Site, Las Vegas, Nevada 89102, United States

Reckitt Benckiser Study Site, Rochester, New York 14609, United States

Reckitt Benckiser Study Site, Raleigh, North Carolina 27607, United States

Reckitt Benckiser Study Site, Cincinnati, Ohio 45246, United States

Reckitt Benckiser Study Site, Middleburg Heights, Ohio 44130, United States

Reckitt Benckiser Study Site, Warwick, Rhode Island 02886, United States

Reckitt Benckiser Study Site, Greer, South Carolina 29651, United States

Reckitt Benckiser Study Site, Dakota Dunes, South Dakota 57049, United States

Reckitt Benckiser Study Site, Franklin, Tennessee 37067, United States

Reckitt Benckiser Study Site, Jackson, Tennessee 38305, United States

Reckitt Benckiser Study Site, New Tazewell, Tennessee 37825, United States

Reckitt Benckiser Study Site, Smyrna, Tennessee 37167, United States

Reckitt Benckiser Study Site, Austin, Texas 78705, United States

Reckitt Benckiser Study Site, Carrollton, Texas 75010, United States

Reckitt Benckiser Study Site, Forth Worth, Texas 76135, United States

Reckitt Benckiser Study Site, San Angelo, Texas 76904, United States

Reckitt Benckiser Study Site, Tomball, Texas 77375, United States

Reckitt Benckiser Study Site, Salt Lake City, Utah 84124, United States

Reckitt Benckiser Study Site, Spokane, Washington 99204, United States

Additional Information

Starting date: September 2011
Last updated: October 22, 2013

Page last updated: August 23, 2015

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