Trial Outcomes & Findings for Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (NCT NCT01202279)
NCT ID: NCT01202279
Last Updated: 2020-12-30
Results Overview
Number of patients who received an antibiotic
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1179 participants
Primary outcome timeframe
Day 7
Results posted on
2020-12-30
Participant Flow
Recruitment took place October 2009 through April 2010. Advertising was not allowed for this study. Patients were seen by a Health Care Provider(HCP) and must have been seeking treatment for symptoms diagnostic for an acute upper respiratory tract infection.
Participant milestones
| Measure |
Mucinex D
Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
|
Placebo
Placebo given bid with a full glass of water for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
591
|
588
|
|
Overall Study
COMPLETED
|
554
|
561
|
|
Overall Study
NOT COMPLETED
|
37
|
27
|
Reasons for withdrawal
| Measure |
Mucinex D
Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
|
Placebo
Placebo given bid with a full glass of water for 7 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
study compliance
|
5
|
2
|
Baseline Characteristics
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
Baseline characteristics by cohort
| Measure |
Mucinex D
n=591 Participants
Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
|
Placebo
n=588 Participants
Placebo given bid with a full glass of water for 7 days
|
Total
n=1179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
575 Participants
n=93 Participants
|
575 Participants
n=4 Participants
|
1150 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 13.7 • n=93 Participants
|
38.8 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
38.1 years
STANDARD_DEVIATION 13.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
395 Participants
n=93 Participants
|
404 Participants
n=4 Participants
|
799 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
196 Participants
n=93 Participants
|
184 Participants
n=4 Participants
|
380 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
591 participants
n=93 Participants
|
588 participants
n=4 Participants
|
1179 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Per Protocol Population using Fishers Exact Test.
Number of patients who received an antibiotic
Outcome measures
| Measure |
Mucinex D
n=510 Participants
Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
|
Placebo
n=523 Participants
Placebo given bid with a full glass of water for 7 days
|
|---|---|---|
|
Antibiotic Sparing
|
89 Participants
|
121 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7 DaysWURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.
Outcome measures
| Measure |
Mucinex D
n=591 Participants
Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
|
Placebo
n=588 Participants
Placebo given bid with a full glass of water for 7 days
|
|---|---|---|
|
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
|
-14.2 units on a scale
Standard Deviation 7.71
|
-13.4 units on a scale
Standard Deviation 7.99
|
Adverse Events
Mucinex D
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mucinex D
n=593 participants at risk
Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
|
Placebo
n=591 participants at risk
Placebo given bid with a full glass of water for 7 days
|
|---|---|---|
|
Psychiatric disorders
Nervousness
|
1.2%
7/593 • Number of events 7 • Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
|
0.68%
4/591 • Number of events 4 • Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
2.9%
17/593 • Number of events 18 • Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
|
0.17%
1/591 • Number of events 1 • Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
|
|
Nervous system disorders
Headache
|
1.2%
7/593 • Number of events 13 • Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
|
2.4%
14/591 • Number of events 21 • Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
|
|
Nervous system disorders
Dizziness
|
1.0%
6/593 • Number of events 6 • Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
|
0.34%
2/591 • Number of events 2 • Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60