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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

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ClinicalTrials.gov Identifier: NCT03725085
Recruitment Status : Completed
First Posted : October 30, 2018
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Subjects
Intervention Drug: Mucinex™ extended-release (SE)
Enrollment 552
Recruitment Details This is a multicentric study conducted in 9 study centres across 7 cities in India.
Pre-assignment Details A total of 554 subjects were screened, 552 subjects enrolled and 550 of them completed the study.
Arm/Group Title Mucinex™
Hide Arm/Group Description Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
Period Title: Overall Study
Started 552
Completed 550
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Mucinex™
Hide Arm/Group Description Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
Overall Number of Baseline Participants 552
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 552 participants
42.3  (15.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 552 participants
Female
203
  36.8%
Male
349
  63.2%
Height  
Mean (Standard Deviation)
Unit of measure:  Cms
Number Analyzed 552 participants
160.8  (8.25)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kgs
Number Analyzed 552 participants
62.5  (11.08)
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 552 participants
Asian
552
 100.0%
others
0
   0.0%
1.Primary Outcome
Title Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
Hide Description

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

Time Frame Up to Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All patients enrolled in the study were included for safety analyses.
Arm/Group Title Mucinex™
Hide Arm/Group Description:
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
Overall Number of Participants Analyzed 552
Measure Type: Number
Unit of Measure: Number of Events
Treatment Emergent Adverse Event (TEAE) 29
Serious TEAE 0
Non serious TEAE 29
Number of Events 29
2.Primary Outcome
Title Number of Subjects Affected With Adverse Events
Hide Description Proportion of patients with AE(s) - Number of Subjects affected with Events
Time Frame Up to Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All patients enrolled in the study were included for safety analyses.
Arm/Group Title Mucinex™
Hide Arm/Group Description:
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
Overall Number of Participants Analyzed 552
Measure Type: Number
Unit of Measure: Number of Subjects affected with Events
28
3.Primary Outcome
Title Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Hide Description

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

Time Frame Up to Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All patients enrolled in the study were included for safety analyses.
Arm/Group Title Mucinex™
Hide Arm/Group Description:
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
Overall Number of Participants Analyzed 552
Measure Type: Number
Unit of Measure: Number of Events
Treatment Emergent Adverse Event (TEAE) 29
Serious TEAE 0
TEAE Leading to Withdrawal 0
TEAE by severity: Mild 29
TEAE by severity: Moderate 0
TEAE by severity: Severe 0
Relationship to IMP – Certain 0
Relationship to IMP – Probable 5
Relationship to IMP – Possible 13
Relationship to IMP - Unlikely 3
Relationship to IMP – Unrelated 8
Relationship to IMP - Conditional/Unclassified 0
Relationship to IMP – Unassessable/Unclassifiable 0
4.Secondary Outcome
Title Overall Assessment of the Study Medication by End of Study Patient Questionnaire
Hide Description

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)

Time Frame Up to Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All patients enrolled in the study were included for safety analyses.
Arm/Group Title Mucinex™
Hide Arm/Group Description:
Subjects received a twice daily dose of Mucinex™ 600mg Guaifenesin extended-release bi-layer tablets every 12hours
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement of Chest Congestion: Very Satisfied
95
  17.2%
Improvement of Chest Congestion: Satisfied
379
  68.7%
Improvement of Chest Congestion: Mostly Satisfied
67
  12.1%
Improvement of Chest Congestion: Not Satisfied
9
   1.6%
Improvement of Chest Congestion: Missing
2
   0.4%
Improvement of Chesty Cough: Very Satisfied
97
  17.6%
Improvement of Chesty Cough: Satisfied
372
  67.4%
Improvement of Chesty Cough: Mostly Satisfied
73
  13.2%
Improvement of Chesty Cough: Not Satisfied
8
   1.4%
Improvement of Chesty Cough: Missing
2
   0.4%
First Improvement: During 1st Day of Treatment
75
  13.6%
First Improvement: At 2 Days Of Treatment
360
  65.2%
First Improvement: Within 3 Days of Treatment
95
  17.2%
First Improvement: More than 3 Days of Treatment
20
   3.6%
First Improvement: Missing
2
   0.4%
Dosing easy to take / convenient: Yes
445
  80.6%
Dosing easy to take / convenient: No
105
  19.0%
Dosing easy to take / convenient: Missing
2
   0.4%
Effective to Treat Chest congestion:Very Satisfied
108
  19.6%
Effective to Treat Chest congestion:Somewhat Stfd
386
  69.9%
Effective to Treat Chest congestion:Somewhat Dstfd
51
   9.2%
Effective to Treat Chest congestion: Dissatisfied
5
   0.9%
Effective to Treat Chest congestion: Missing
2
   0.4%
Effective to Treat Chesty cough: Very Satisfied
149
  27.0%
Effective to Treat Chesty cough:Somewhat Satisfied
361
  65.4%
Effective to Treat Chesty cough: Somewhat Dstfd
34
   6.2%
Effective to Treat Chesty cough: Dissatisfied
6
   1.1%
Effective to Treat Chesty cough: Missing
2
   0.4%
Recommend to Family and friends: Yes
305
  55.3%
Recommend to Family and friends: Maybe
216
  39.1%
Recommend to Family and friends: No
10
   1.8%
Recommend to Family and friends: Missing
21
   3.8%
Mucinex as first choice
171
  31.0%
Mucinex as top two options
133
  24.1%
Mucinex as alternative, But not primary
1
   0.2%
5.Secondary Outcome
Title Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
Hide Description

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)

Time Frame Up to Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All patients enrolled in the study were included for safety analyses.
Arm/Group Title Mucinex™
Hide Arm/Group Description:
Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
Overall Number of Participants Analyzed 552
Measure Type: Number
Unit of Measure: Number of investigator
Treatment outcome with URTIs taking Mucinex: MS 2
Treatment outcome with URTIs taking Mucinex: Stfd 5
Treatment outcome with URTIs taking Mucinex: VS 2
Patient satisfaction with the treatment of CC: NS 1
Patient satisfaction with the treatment of CC:Stfd 5
Patient satisfaction with the treatment of CC: VS 3
Patient satisfaction with the treatment of CCO: MS 1
Patient satisfaction with treatment of CCO:Stfd 5
Patient satisfaction with the treatment of CCO: VS 3
Reported Improvements: At 2 Days Of Treatment 5
Reported Improvements:Within 3 Days of Treatment 4
Treatment Diff b/w CC & CCO congestion: CC first 7
Treatment Diff b/w CC & CCO congestion:Cough first 2
Treatment recommend for CC with URTI Patient:Agree 5
Treatment recommend for CC with URTI Patient: SA 1
Treatment recommend for CC with URTI Patient: StA 3
Opt dos for treating CC compare to other CPA: No 1
Opt dos for treating CC compare to other CPA: Yes 8
Time Frame Up to End of Study (Day 9)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mucinex™
Hide Arm/Group Description Subjects received a twice daily dose of Mucinex™ 600 mg Guaifenesin extended-release bi-layer tablets every 12hours
All-Cause Mortality
Mucinex™
Affected / at Risk (%)
Total   0/552 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mucinex™
Affected / at Risk (%) # Events
Total   0/552 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mucinex™
Affected / at Risk (%) # Events
Total   28/552 (5.07%)    
Gastrointestinal disorders   
Abdominal Pain  1  1/552 (0.18%)  1
Abdominal Pain Upper  1  4/552 (0.72%)  4
Diarrhoea  1  3/552 (0.54%)  3
Dry Mouth  1  1/552 (0.18%)  1
Nausea  1  2/552 (0.36%)  2
General disorders   
Malaise  1  2/552 (0.36%)  2
Pain  1  1/552 (0.18%)  1
Nervous system disorders   
Dizziness  1  4/552 (0.72%)  4
Headache  1  4/552 (0.72%)  4
Psychiatric disorders   
Anxiety  1  3/552 (0.54%)  3
Respiratory, thoracic and mediastinal disorders   
Rhinorrhoea  1  2/552 (0.36%)  2
Skin and subcutaneous tissue disorders   
Pruritus  1  2/552 (0.36%)  2
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Director, Clinical Research
Organization: Reckitt Benckiser Inc.
EMail: clinicalrequests@rb.com
Layout table for additonal information
Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT03725085     History of Changes
Other Study ID Numbers: 2012-MUC-PMS-IN
First Submitted: October 29, 2018
First Posted: October 30, 2018
Results First Submitted: November 19, 2018
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019