Trial Outcomes & Findings for Mucinex Exploratory Cold Study (NCT NCT01046136)

NCT ID: NCT01046136

Last Updated: 2020-12-30

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 378 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2020-12-30

Participant Flow

Participants were recruited from waiting rooms of health care providers/clinics between December 2009 and March 2010.

Participants screened over 2 day period who suffer from an acute respiratory tract infection.

Participant milestones

Measure	Mucinex 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS	Placebo 2 TABLETS EVERY 12 HOURS FOR 7 DAYS
Overall Study STARTED	188	190
Overall Study COMPLETED	184	182
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Measure	Mucinex 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS	Placebo 2 TABLETS EVERY 12 HOURS FOR 7 DAYS
Overall Study Withdrawal by Subject	0	4
Overall Study Physician Decision	1	1
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Mucinex Exploratory Cold Study

Baseline characteristics by cohort

Measure	Mucinex n=188 Participants 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS	Placebo n=190 Participants 2 TABLETS EVERY 12 HOURS FOR 7 DAYS	Total n=378 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	178 Participants n=5 Participants	175 Participants n=7 Participants	353 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Continuous	41.1 years STANDARD_DEVIATION 13.91 • n=5 Participants	40.8 years STANDARD_DEVIATION 15.04 • n=7 Participants	41.0 years STANDARD_DEVIATION 14.47 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	84 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	106 Participants n=7 Participants	198 Participants n=5 Participants
Region of Enrollment United States	188 participants n=5 Participants	190 participants n=7 Participants	378 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: 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.

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

Outcome measures

Measure	Mucinex n=178 Participants Two 600mg tablets taken taken twice daily	Placebo n=180 Participants Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
Investigator's End of Study Assessment of Treatment	163 participants	149 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Mucinex n=183 Participants Two 600mg tablets taken taken twice daily	Placebo n=186 Participants Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
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.	-1.1 units on a scale Standard Deviation 0.14	-0.9 units on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: 7 days

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

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

Outcome measures

Measure	Mucinex n=188 Participants Two 600mg tablets taken taken twice daily	Placebo n=189 Participants Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
Number of Patients With Adverse Events	12 participants	6 participants

Adverse Events

Mucinex

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mucinex n=188 participants at risk 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS	Placebo n=189 participants at risk 2 TABLETS EVERY 12 HOURS FOR 7 DAYS
Cardiac disorders arrhythmia supraventricular	0.53% 1/188 • Number of events 1 • 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.	0.00% 0/189 • 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.
Infections and infestations Endocarditis	0.53% 1/188 • Number of events 1 • 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.	0.00% 0/189 • 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.
Injury, poisoning and procedural complications Lymphatic duct injury	0.53% 1/188 • Number of events 1 • 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.	0.00% 0/189 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.53% 1/188 • Number of events 1 • 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.	0.00% 0/189 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Kim Clark

Reckitt Benckiser

Phone: 855.966.5483

Email: ClinicalRequests@rb.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60