Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
Public ClinicalTrials.gov record NCT01537081. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01537081
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 2,810 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2011 (Type not available)
- Primary completion
- Mar 2012 (Actual)
- Completion
- Jul 2012 (Actual)
- Last update posted
- Nov 14, 2013
2011 – 2012
United States locations
- U.S. sites
- 43
- U.S. states
- 21
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Reckitt Benckiser Study Site | Hoover | Alabama | 35216 | — |
| Reckitt Benckiser Study Site | Bell Gardens | California | 90201 | — |
| Reckitt Benckiser Study Site | Harbor City | California | 90710 | — |
| Reckitt Benckiser Study Site | Long Beach | California | 90813 | — |
| Reckitt Benckiser Study Site | Sacramento | California | 95816 | — |
| Reckitt Benckiser Study Site | San Francisco | California | 94102 | — |
| Reckitt Benckiser Study Site | San Luis Obispo | California | 93405 | — |
| Reckitt Benckiser Study Site | Colorado Springs | Colorado | 80907 | — |
| Reckitt Benckiser Study Site | Denver | Colorado | 80239 | — |
| Reckitt Benckiser Study Site | Daytona Beach | Florida | 32117 | — |
| Reckitt Benckiser Study Site | Edgewater | Florida | 32132 | — |
| Reckitt Benckiser Study Site | Largo | Florida | 33710 | — |
| Reckitt Benckiser Study Site | Chicago | Illinois | 60624 | — |
| Reckitt Benckiser Study Site | Normal | Illinois | 61761 | — |
| Reckitt Benckiser Study Site | Wichita | Kansas | 67207 | — |
| Reckitt Benckiser Study Site | Lexington | Kentucky | 40509 | — |
| Reckitt Benckiser Study Site | Metairie | Louisiana | 70006 | — |
| Reckitt Benckiser Study Site | New Orleans | Louisiana | 70115 | — |
| Reckitt Benckiser Study Site | Brighton | Massachusetts | 02135 | — |
| Reckitt Benckiser Study Site | Fall River | Massachusetts | 02720 | — |
| Reckitt Benckiser Study Site | Bellevue | Nebraska | 68005 | — |
| Reckitt Benckiser Study Site | Omaha | Nebraska | 68114 | — |
| Reckitt Benckiser Study Site | Omaha | Nebraska | 68134 | — |
| Reckitt Benckiser Study Site | Las Vegas | Nevada | 89102 | — |
| Reckitt Benckiser Study Site | Las Vegas | Nevada | 89119 | — |
| Reckitt Benckiser Study Site | Rochester | New York | 14609 | — |
| Reckitt Benckiser Study Site | Raleigh | North Carolina | 27607 | — |
| Reckitt Benckiser Study Site | Cincinnati | Ohio | 45246 | — |
| Reckitt Benckiser Study Site | Middleburg Heights | Ohio | 44130 | — |
| Reckitt Benckiser Study Site | Warwick | Rhode Island | 02886 | — |
| Reckitt Benckiser Study Site | Greer | South Carolina | 29651 | — |
| Reckitt Benckiser Study Site | Dakota Dunes | South Dakota | 57049 | — |
| Reckitt Benckiser Study Site | Franklin | Tennessee | 37067 | — |
| Reckitt Benckiser Study Site | Jackson | Tennessee | 38305 | — |
| Reckitt Benckiser Study Site | New Tazewell | Tennessee | 37825 | — |
| Reckitt Benckiser Study Site | Smyrna | Tennessee | 37167 | — |
| Reckitt Benckiser Study Site | Austin | Texas | 78705 | — |
| Reckitt Benckiser Study Site | Carrollton | Texas | 75010 | — |
| Reckitt Benckiser Study Site | Forth Worth | Texas | 76135 | — |
| Reckitt Benckiser Study Site | San Angelo | Texas | 76904 | — |
| Reckitt Benckiser Study Site | Tomball | Texas | 77375 | — |
| Reckitt Benckiser Study Site | Salt Lake City | Utah | 84124 | — |
| Reckitt Benckiser Study Site | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01537081, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 14, 2013 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01537081 live on ClinicalTrials.gov.