Trial Outcomes & Findings for Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections (NCT NCT01537081)
NCT ID: NCT01537081
Last Updated: 2013-11-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
2810 participants
Primary outcome timeframe
Day 4
Results posted on
2013-11-14
Participant Flow
A total of 3215 patients were screened for enrollment, and 405 did not proceed in the study. Participants were randomized in a 2:2:1 ratio.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1123
|
1124
|
563
|
|
Overall Study
Safety Population
|
1122
|
1122
|
561
|
|
Overall Study
Modified Intent to Treat Population
|
1106
|
1109
|
556
|
|
Overall Study
COMPLETED
|
1084
|
1086
|
547
|
|
Overall Study
NOT COMPLETED
|
39
|
38
|
16
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
17
|
15
|
9
|
|
Overall Study
Protocol Violation
|
3
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
11
|
3
|
|
Overall Study
Physician Decision
|
5
|
6
|
0
|
|
Overall Study
Sponsor decision
|
0
|
1
|
0
|
|
Overall Study
Assigned but never dosed
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
Baseline characteristics by cohort
| Measure |
Mucinex 2400 mg/Day
n=1122 Participants
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.
|
Immediate-release Guaifenesin 800 mg/Day
n=1122 Participants
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.
|
Placebo
n=561 Participants
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.
|
Total
n=2805 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
37.3 years
STANDARD_DEVIATION 13.81 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 13.81 • n=7 Participants
|
37.9 years
STANDARD_DEVIATION 14.09 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 13.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
670 Participants
n=5 Participants
|
668 Participants
n=7 Participants
|
333 Participants
n=5 Participants
|
1671 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
452 Participants
n=5 Participants
|
454 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
1134 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
31 participants
n=5 Participants
|
25 participants
n=7 Participants
|
13 participants
n=5 Participants
|
69 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
382 participants
n=5 Participants
|
419 participants
n=7 Participants
|
200 participants
n=5 Participants
|
1001 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
686 participants
n=5 Participants
|
656 participants
n=7 Participants
|
327 participants
n=5 Participants
|
1669 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
46 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 4Population: 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.
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.
Outcome measures
| Measure |
Mucinex 2400 mg/Day
n=1064 Participants
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.
|
Immediate-release Guaifenesin 800 mg/Day
n=1081 Participants
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.
|
Placebo
n=542 Participants
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.
|
|---|---|---|---|
|
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4
|
12.96 units on a scale
Standard Deviation 6.226
|
12.87 units on a scale
Standard Deviation 6.078
|
12.71 units on a scale
Standard Deviation 5.828
|
PRIMARY outcome
Timeframe: Day 5Population: 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.
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.
Outcome measures
| Measure |
Mucinex 2400 mg/Day
n=1065 Participants
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.
|
Immediate-release Guaifenesin 800 mg/Day
n=1060 Participants
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.
|
Placebo
n=537 Participants
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.
|
|---|---|---|---|
|
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5
|
10.92 units on a scale
Standard Deviation 6.448
|
10.80 units on a scale
Standard Deviation 6.261
|
11.05 units on a scale
Standard Deviation 5.900
|
Adverse Events
Mucinex 2400 mg/Day
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
Immediate-release Guaifenesin 800 mg/Day
Serious events: 0 serious events
Other events: 85 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mucinex 2400 mg/Day
n=1122 participants at risk
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.
|
Immediate-release Guaifenesin 800 mg/Day
n=1122 participants at risk
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.
|
Placebo
n=561 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.00%
0/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.18%
1/561 • Number of events 1 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
Other adverse events
| Measure |
Mucinex 2400 mg/Day
n=1122 participants at risk
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.
|
Immediate-release Guaifenesin 800 mg/Day
n=1122 participants at risk
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.
|
Placebo
n=561 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
21/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
1.5%
17/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
1.6%
9/561 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
18/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
1.7%
19/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
1.1%
6/561 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
7/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.27%
3/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.71%
4/561 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
|
General disorders
Pyrexia
|
0.18%
2/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.45%
5/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.53%
3/561 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
|
Nervous system disorders
Dizziness
|
0.89%
10/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.71%
8/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.53%
3/561 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
|
Nervous system disorders
Headache
|
2.0%
22/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
2.4%
27/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
2.0%
11/561 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
|
Nervous system disorders
Somnolence
|
0.36%
4/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.53%
6/1122 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
0.89%
5/561 • Treatment-emergent timeframe: Day 1 to Day 7
The safety population included all patients who received the study medication, excluding patients who later returned all the dispensed study medication to the site.
|
Additional Information
Gail Solomon,MS; Director Clinical Development
Reckitt Benckiser LLC
Phone: 973-404-2752
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60