Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Acute Upper Respiratory Tract Infection
In brief
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.
Key facts
- Study ID
- NCT01537081
- Run by
- Reckitt Benckiser LLC
- People needed
- 2810
- Starts
- 2011-09-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2013-11-14
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has developed cold symptoms within 3 days prior to dosing on Day 1.
You may not qualify if…
- Chronic illnesses.
- Febrile illness > 101 F within 7 days prior to Day 1,
- Pregnant.
- Known current malignancy.
Where it is running
- Reckitt Benckiser Study Site — Hoover, Alabama, United States
- Reckitt Benckiser Study Site — Bell Gardens, California, United States
- Reckitt Benckiser Study Site — Harbor City, California, United States
- Reckitt Benckiser Study Site — Long Beach, California, United States
- Reckitt Benckiser Study Site — Sacramento, California, United States
- Reckitt Benckiser Study Site — San Francisco, California, United States
- Reckitt Benckiser Study Site — San Luis Obispo, California, United States
- Reckitt Benckiser Study Site — Colorado Springs, Colorado, United States
- Reckitt Benckiser Study Site — Denver, Colorado, United States
- Reckitt Benckiser Study Site — Daytona Beach, Florida, United States
- Reckitt Benckiser Study Site — Edgewater, Florida, United States
- Reckitt Benckiser Study Site — Largo, Florida, United States
- Reckitt Benckiser Study Site — Chicago, Illinois, United States
- Reckitt Benckiser Study Site — Normal, Illinois, United States
- Reckitt Benckiser Study Site — Wichita, Kansas, United States
- Reckitt Benckiser Study Site — Lexington, Kentucky, United States
- Reckitt Benckiser Study Site — Metairie, Louisiana, United States
- Reckitt Benckiser Study Site — New Orleans, Louisiana, United States
- Reckitt Benckiser Study Site — Brighton, Massachusetts, United States
- Reckitt Benckiser Study Site — Fall River, Massachusetts, United States
- Reckitt Benckiser Study Site — Bellevue, Nebraska, United States
- Reckitt Benckiser Study Site — Omaha, Nebraska, United States
- Reckitt Benckiser Study Site — Omaha, Nebraska, United States
- Reckitt Benckiser Study Site — Las Vegas, Nevada, United States
- Reckitt Benckiser Study Site — Las Vegas, Nevada, United States
Full record on ClinicalTrials.gov
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