Clinical trial NCT01537081: Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Upper Respiratory Tract Infection
Lead sponsor: Reckitt Benckiser LLC
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 2810
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4
timeFrame: Day 4
measure: Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5
timeFrame: Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Reckitt Benckiser Study Site
state: Alabama
city: Bell Gardens
country: United States
facility: Reckitt Benckiser Study Site
state: California
city: Harbor City
country: United States
facility: Reckitt Benckiser Study Site
state: California
city: Long Beach
country: United States
facility: Reckitt Benckiser Study Site
state: California
city: Sacramento
country: United States
facility: Reckitt Benckiser Study Site
state: California
city: San Francisco
country: United States
facility: Reckitt Benckiser Study Site
state: California
city: San Luis Obispo
country: United States
facility: Reckitt Benckiser Study Site
state: California
city: Colorado Springs
country: United States
facility: Reckitt Benckiser Study Site
state: Colorado
city: Denver
country: United States
facility: Reckitt Benckiser Study Site
state: Colorado
city: Daytona Beach
country: United States
facility: Reckitt Benckiser Study Site
state: Florida
city: Edgewater
country: United States
facility: Reckitt Benckiser Study Site
state: Florida
city: Largo
country: United States
facility: Reckitt Benckiser Study Site
state: Florida
city: Chicago
country: United States
facility: Reckitt Benckiser Study Site
state: Illinois
city: Normal
country: United States
facility: Reckitt Benckiser Study Site
state: Illinois
city: Wichita
country: United States
facility: Reckitt Benckiser Study Site
state: Kansas
city: Lexington
country: United States
facility: Reckitt Benckiser Study Site
state: Kentucky
city: Metairie
country: United States
facility: Reckitt Benckiser Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Reckitt Benckiser Study Site
state: Louisiana
city: Brighton
country: United States
facility: Reckitt Benckiser Study Site
state: Massachusetts
city: Fall River
country: United States
facility: Reckitt Benckiser Study Site
state: Massachusetts
city: Bellevue
country: United States
facility: Reckitt Benckiser Study Site
state: Nebraska
city: Omaha
country: United States
facility: Reckitt Benckiser Study Site
state: Nebraska
city: Omaha
country: United States
facility: Reckitt Benckiser Study Site
state: Nebraska
city: Las Vegas
country: United States
facility: Reckitt Benckiser Study Site
state: Nevada
city: Las Vegas
country: United States
facility: Reckitt Benckiser Study Site
state: Nevada
city: Rochester
country: United States
facility: Reckitt Benckiser Study Site
state: New York
city: Raleigh
country: United States
facility: Reckitt Benckiser Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Reckitt Benckiser Study Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Reckitt Benckiser Study Site
state: Ohio
city: Warwick
country: United States
facility: Reckitt Benckiser Study Site
state: Rhode Island
city: Greer
country: United States
facility: Reckitt Benckiser Study Site
state: South Carolina
city: Dakota Dunes
country: United States
facility: Reckitt Benckiser Study Site
state: South Dakota
city: Franklin
country: United States
facility: Reckitt Benckiser Study Site
state: Tennessee
city: Jackson
country: United States
facility: Reckitt Benckiser Study Site
state: Tennessee
city: New Tazewell
country: United States
facility: Reckitt Benckiser Study Site
state: Tennessee
city: Smyrna
country: United States
facility: Reckitt Benckiser Study Site
state: Tennessee
city: Austin
country: United States
facility: Reckitt Benckiser Study Site
state: Texas
city: Carrollton
country: United States
facility: Reckitt Benckiser Study Site
state: Texas
city: Forth Worth
country: United States
facility: Reckitt Benckiser Study Site
state: Texas
city: San Angelo
country: United States
facility: Reckitt Benckiser Study Site
state: Texas
city: Tomball
country: United States
facility: Reckitt Benckiser Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Reckitt Benckiser Study Site
state: Utah
city: Spokane
country: United States
facility: Reckitt Benckiser Study Site
state: Washington
Study officials:
References: