Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of Mucinex™(Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest Congestion (NCT NCT03725085)
NCT ID: NCT03725085
Last Updated: 2019-03-19
Results Overview
Treatment Emergent Adverse Event (TEAE) are events occurring after the first dose of study medication. Frequency of AE(s) - the total Number of Events Type of AE(s) - Serious TEAE and Non serious TEAE
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
552 participants
Primary outcome timeframe
Up to Day 9
Results posted on
2019-03-19
Participant Flow
This is a multicentric study conducted in 9 study centres across 7 cities in India.
A total of 554 subjects were screened, 552 subjects enrolled and 550 of them completed the study.
Participant milestones
| Measure |
Mucinex™
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Overall Study
STARTED
|
552
|
|
Overall Study
COMPLETED
|
550
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Mucinex™
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Study to Evaluate the Safety and Tolerability of Mucinex™(Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest Congestion
Baseline characteristics by cohort
| Measure |
Mucinex™
n=552 Participants
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 15.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
203 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
349 Participants
n=5 Participants
|
|
Height
|
160.8 cms
STANDARD_DEVIATION 8.25 • n=5 Participants
|
|
Weight
|
62.5 Kgs
STANDARD_DEVIATION 11.08 • n=5 Participants
|
|
Race
Asian
|
552 Participants
n=5 Participants
|
|
Race
others
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 9Population: Safety Population: All patients enrolled in the study were included for safety analyses.
Treatment Emergent Adverse Event (TEAE) are events occurring after the first dose of study medication. Frequency of AE(s) - the total Number of Events Type of AE(s) - Serious TEAE and Non serious TEAE
Outcome measures
| Measure |
Mucinex™
n=552 Participants
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
Treatment Emergent Adverse Event (TEAE)
|
29 Number of Events
|
|
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
Serious TEAE
|
0 Number of Events
|
|
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
Non serious TEAE
|
29 Number of Events
|
|
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
Number of Events
|
29 Number of Events
|
PRIMARY outcome
Timeframe: Up to Day 9Population: Safety Population: All patients enrolled in the study were included for safety analyses.
Proportion of patients with AE(s) - Number of Subjects affected with Events
Outcome measures
| Measure |
Mucinex™
n=552 Participants
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Number of Subjects Affected With Adverse Events
|
28 Number of Subjects affected with Events
|
PRIMARY outcome
Timeframe: Up to Day 9Population: Safety Population: All patients enrolled in the study were included for safety analyses.
Intensity determined. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unassessable/Unclassified = Insufficient information to be able to make an assessment Conditional/ Unclassified = Insufficient information to make an assessment at present Unrelated = No possibility that the AE was caused by the IMP Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment was that it was most likely not due to the IMP. Possible = Reasonable suspicion that the AE was caused by the IMP Probable = Most likely that the AE was caused by the IMP Certain = AE was definitely caused by the IMP
Outcome measures
| Measure |
Mucinex™
n=552 Participants
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Treatment Emergent Adverse Event (TEAE)
|
29 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Serious TEAE
|
0 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
TEAE Leading to Withdrawal
|
0 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
TEAE by severity: Mild
|
29 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
TEAE by severity: Moderate
|
0 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
TEAE by severity: Severe
|
0 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Relationship to IMP - Certain
|
0 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Relationship to IMP - Probable
|
5 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Relationship to IMP - Possible
|
13 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Relationship to IMP - Unlikely
|
3 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Relationship to IMP - Unrelated
|
8 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Relationship to IMP - Conditional/Unclassified
|
0 Number of Events
|
|
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Relationship to IMP - Unassessable/Unclassifiable
|
0 Number of Events
|
SECONDARY outcome
Timeframe: Up to Day 9Population: Safety Population: All patients enrolled in the study were included for safety analyses.
End of Study Patient Questionnaire is a questionnaire provided to the patients for overall assessment of the study medication at the end of study visit. Satisfied(stfd) Dissatisfied(Dstfd)
Outcome measures
| Measure |
Mucinex™
n=552 Participants
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chest Congestion: Very Satisfied
|
95 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chest Congestion: Satisfied
|
379 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chest Congestion: Mostly Satisfied
|
67 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chest Congestion: Not Satisfied
|
9 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chest Congestion: Missing
|
2 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chesty Cough: Very Satisfied
|
97 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chesty Cough: Satisfied
|
372 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chesty Cough: Mostly Satisfied
|
73 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chesty Cough: Not Satisfied
|
8 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Improvement of Chesty Cough: Missing
|
2 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
First Improvement: During 1st Day of Treatment
|
75 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
First Improvement: At 2 Days Of Treatment
|
360 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
First Improvement: Within 3 Days of Treatment
|
95 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
First Improvement: More than 3 Days of Treatment
|
20 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
First Improvement: Missing
|
2 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Dosing easy to take / convenient: Yes
|
445 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Dosing easy to take / convenient: No
|
105 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Dosing easy to take / convenient: Missing
|
2 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chest congestion:Very Satisfied
|
108 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chest congestion:Somewhat Stfd
|
386 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chest congestion:Somewhat Dstfd
|
51 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chest congestion: Dissatisfied
|
5 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chest congestion: Missing
|
2 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chesty cough: Very Satisfied
|
149 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chesty cough:Somewhat Satisfied
|
361 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chesty cough: Somewhat Dstfd
|
34 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chesty cough: Dissatisfied
|
6 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Effective to Treat Chesty cough: Missing
|
2 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Recommend to Family and friends: Yes
|
305 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Recommend to Family and friends: Maybe
|
216 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Recommend to Family and friends: No
|
10 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Recommend to Family and friends: Missing
|
21 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Mucinex as first choice
|
171 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Mucinex as top two options
|
133 Participants
|
|
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Mucinex as alternative, But not primary
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: Safety Population: All patients enrolled in the study were included for safety analyses.
End of Study Investigator Questionnaire is a questionnaire provided at the end of study visit to the investigator (or sub-investigator as applicable) for overall assessment of the study medication across all patients treated by them. End of study investigator questionnaire was collected from 9 investigators. Mostly Satisfied(MS) Satisfied(Stfd) Very Satisfied(VS) Chest Congestion(CC) Chesty Cough(CCO) Difference(Diff) Between(b/w) Somewhat Agree(SA) Strongly Agree(StA) Upper respiratory tract infection(URTI) Optimal dosage(Opt dos) Cough preparations Available(CPA)
Outcome measures
| Measure |
Mucinex™
n=552 Participants
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Treatment outcome with URTIs taking Mucinex: Stfd
|
5 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Reported Improvements:Within 3 Days of Treatment
|
4 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Treatment outcome with URTIs taking Mucinex: MS
|
2 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Treatment outcome with URTIs taking Mucinex: VS
|
2 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Patient satisfaction with the treatment of CC: NS
|
1 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Patient satisfaction with the treatment of CC:Stfd
|
5 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Patient satisfaction with the treatment of CC: VS
|
3 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Patient satisfaction with the treatment of CCO: MS
|
1 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Patient satisfaction with treatment of CCO:Stfd
|
5 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Patient satisfaction with the treatment of CCO: VS
|
3 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Reported Improvements: At 2 Days Of Treatment
|
5 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Treatment Diff b/w CC & CCO congestion: CC first
|
7 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Treatment Diff b/w CC & CCO congestion:Cough first
|
2 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Treatment recommend for CC with URTI Patient:Agree
|
5 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Treatment recommend for CC with URTI Patient: SA
|
1 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Treatment recommend for CC with URTI Patient: StA
|
3 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Opt dos for treating CC compare to other CPA: No
|
1 Number of investigator
|
|
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Opt dos for treating CC compare to other CPA: Yes
|
8 Number of investigator
|
Adverse Events
Mucinex™
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mucinex™
n=552 participants at risk
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.18%
1/552 • Number of events 1 • Up to End of Study (Day 9)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.72%
4/552 • Number of events 4 • Up to End of Study (Day 9)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.54%
3/552 • Number of events 3 • Up to End of Study (Day 9)
|
|
Gastrointestinal disorders
Dry Mouth
|
0.18%
1/552 • Number of events 1 • Up to End of Study (Day 9)
|
|
Gastrointestinal disorders
Nausea
|
0.36%
2/552 • Number of events 2 • Up to End of Study (Day 9)
|
|
General disorders
Malaise
|
0.36%
2/552 • Number of events 2 • Up to End of Study (Day 9)
|
|
General disorders
Pain
|
0.18%
1/552 • Number of events 1 • Up to End of Study (Day 9)
|
|
Nervous system disorders
Dizziness
|
0.72%
4/552 • Number of events 4 • Up to End of Study (Day 9)
|
|
Nervous system disorders
Headache
|
0.72%
4/552 • Number of events 4 • Up to End of Study (Day 9)
|
|
Psychiatric disorders
Anxiety
|
0.54%
3/552 • Number of events 3 • Up to End of Study (Day 9)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.36%
2/552 • Number of events 2 • Up to End of Study (Day 9)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.36%
2/552 • Number of events 2 • Up to End of Study (Day 9)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place