Mucinex Exploratory Cold Study

• Sponsor: Reckitt Benckiser Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01046136
• Collaborator: (none)
• Enrollment: 378
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.

Condition or Disease	Intervention/Treatment	Phase
Common Cold	Drug: guaifenesin (Mucinex); Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 378 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mucinex	Drug: guaifenesin (Mucinex); bid 7 days
Placebo Comparator: placebo	Drug: placebo; bid 7 days

Outcome Measures

Primary Outcome Measures

1. Investigator's End of Study Assessment of Treatment [7 days]

   Yes the investigator would use this treatment for cold symptoms in the future.

2. Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. [Baseline and Day 4]

   Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.

Secondary Outcome Measures

1. Number of Patients With Adverse Events [7 days]

   Total number of patients with adverse events that were possibly or probably related.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• common cold symptoms

• meet symptom severity

• females of child-bearing potential must have negative pregnancy test and use effective birth control

Exclusion Criteria:

• chronic respiratory conditions

• significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder

• pregnant or lactating

• known malignancy

• participation in any other clinical trial within 30 days of baseline

• related to another enrolled patient or persons involved directly or indirectly with the conduct of this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pioneer Clinical Research	Bellevue	Nebraska	United States	68005

Sponsors and Collaborators

• Reckitt Benckiser Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reckitt Benckiser Inc.
• ClinicalTrials.gov Identifier: NCT01046136
• Other Study ID Numbers: 2009-MUC-03
• First Posted: Jan 11, 2010
• Last Update Posted: Dec 30, 2020
• Last Verified: Dec 1, 2020

• Keywords provided by Reckitt Benckiser Inc.: common cold
• Additional relevant MeSH terms: Common Cold; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination

Study Results

Participant Flow

Recruitment Details	Participants were recruited from waiting rooms of health care providers/clinics between December 2009 and March 2010.
Pre-assignment Detail	Participants screened over 2 day period who suffer from an acute respiratory tract infection.

Arm/Group Title	Mucinex	Placebo
Arm/Group Description	2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS	2 TABLETS EVERY 12 HOURS FOR 7 DAYS
Period Title: Overall Study
STARTED	188	190
COMPLETED	184	182
NOT COMPLETED	4	8

Baseline Characteristics

Arm/Group Title	Mucinex	Placebo	Total
Arm/Group Description	2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS	2 TABLETS EVERY 12 HOURS FOR 7 DAYS	Total of all reporting groups
Overall Participants	188	190	378
Age (Count of Participants)
<=18 years	1 0.5%	5 2.6%	6 1.6%
Between 18 and 65 years	178 94.7%	175 92.1%	353 93.4%
>=65 years	9 4.8%	10 5.3%	19 5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.1 (13.91)	40.8 (15.04)	41.0 (14.47)
Sex: Female, Male (Count of Participants)
Female	96 51.1%	84 44.2%	180 47.6%
Male	92 48.9%	106 55.8%	198 52.4%
Region of Enrollment (participants) [Number]
United States	188 100%	190 100%	378 100%

Outcome Measures

1. Primary Outcome

Title	Investigator's End of Study Assessment of Treatment
Description	Yes the investigator would use this treatment for cold symptoms in the future.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

MITT defined as all participants receiving at least 1 dose of study medication and had 1 or more efficacy assessment after Baseline. Last observation carried forward method was applied to missing post baseline measurement in the analyses of the MITT population.

Arm/Group Title	Mucinex	Placebo
Arm/Group Description	Two 600mg tablets taken taken twice daily	Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
Measure Participants	178	180
Number [participants]	163 86.7%	149 78.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mucinex, Placebo
	Comments	Investigator's End-of-Study Assessment NOTE: All assessments of efficacy were considered exploratory and were given equal consideration, and were carried out on both the MITT and PP populations. LOCF method was applied to missing post baseline measurements in analyses of the MITT population.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0096
	Comments
	Method	Regression, Logistic
	Comments	p-value is from a logistic regression model with terms for treatment group and center

2. Secondary Outcome

Title	Number of Patients With Adverse Events
Description	Total number of patients with adverse events that were possibly or probably related.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

All participants who received study medication, excluding participants who later returned all the dispensed study medication to the site unused.

Arm/Group Title	Mucinex	Placebo
Arm/Group Description	2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS	2 TABLETS EVERY 12 HOURS FOR 7 DAYS
Measure Participants	188	189
Number [participants]	12 6.4%	6 3.2%

3. Primary Outcome

Title	Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.
Description	Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.
Time Frame	Baseline and Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mucinex	Placebo
Arm/Group Description	Two 600mg tablets taken taken twice daily	Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
Measure Participants	183	186
Mean (Standard Deviation) [units on a scale]	-1.1 (0.14)	-0.9 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mucinex, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0293
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	P-value is from a Wilcoxon rank sum test comparing the two treatment groups.

Adverse Events

Time Frame	Adverse event data was collected through the treatment period. All patients who received at least 1 dose of study medication were included in the safety analysis.
Arm/Group Title	Mucinex		Placebo
Arm/Group Description	2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS		2 TABLETS EVERY 12 HOURS FOR 7 DAYS
All Cause Mortality
	Mucinex		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mucinex		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/188 (0.5%)		0/189 (0%)
Cardiac disorders
arrhythmia supraventricular	1/188 (0.5%)	1	0/189 (0%)	0
Infections and infestations
Endocarditis	1/188 (0.5%)	1	0/189 (0%)	0
Injury, poisoning and procedural complications
Lymphatic duct injury	1/188 (0.5%)	1	0/189 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/188 (0.5%)	1	0/189 (0%)	0
Other (Not Including Serious) Adverse Events
	Mucinex		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/188 (0%)		0/189 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.