Safety and Efficacy of Mucinex and IR Guaifenesin the Tre... | NCT01537081

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mucinex 2400 mg/day	Experimental	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.	Drug: Mucinex Drug: Placebo
Immediate-release Guaifenesin 800 mg/Day	Active Comparator	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.	Drug: Immediate-release Guaifenesin Drug: Placebo
Placebo	Placebo Comparator	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.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mucinex	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4	Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.	Day 4
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5	Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.	Day 5

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Reckitt Benckiser Study Site		Hoover	Alabama	35216	United States
Reckitt Benckiser Study Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.

Modified Intent-To-Treat (i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 4 are included.

Posted

Mean

Standard Deviation

units on a scale

Day 4

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG0001064 OG0011081 OG002542

Title

Denominators

Categories

Title	Measurements
	OG00012.96± 6.226 OG00112.87± 6.078 OG00212.71± 5.828

Primary

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

Modified Intent-to-Treat(i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 5 are included.

Posted

Mean

Standard Deviation

units on a scale

Day 5

ID	Title	Description
OG000	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.
OG001	Immediate-release Guaifenesin 800 mg/Day

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	1,122	84	1,122
EG001	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.	0	1,122	85	1,122
EG002	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.	1	561	41	561

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00021 affected1,122 at risk EG00117 affected1,122 at risk EG0029 affected561 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00018 affected1,122 at risk EG00119 affected1,122 at risk EG0026 affected561 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0007 affected1,122 at risk EG0013 affected1,122 at risk EG0024 affected561 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected1,122 at risk EG0015 affected1,122 at risk EG0023 affected561 at risk
Dizziness	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00010 affected1,122 at risk EG0018 affected1,122 at risk EG0023 affected561 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00022 affected1,122 at risk EG00127 affected1,122 at risk EG00211 affected561 at risk
Somnolence	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected1,122 at risk EG0016 affected1,122 at risk EG0025 affected561 at risk

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D006139	Guaiacol
D008738	Methyl Ethers
D004987	Ethers
D010647	Phenyl Ethers
D002396	Catechols
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons