Trial · NCT03725085

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

NCT03725085, Phase 4, Completed, Reckitt Benckiser LLC; results first posted 2019-03-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT03725085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03725085

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT03725085
Status: Completed
Phases: Phase 4
Enrollment: 552 participants, actual
Lead sponsor: Reckitt Benckiser LLC
Conditions: Healthy Subjects
Interventions: Mucinex™ extended-release (SE)
First posted: 2018-10-30
Last updated: 2019-03-19
Results first posted: 2019-03-19

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)	Up to Day 9	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
Primary	Number of Subjects Affected With Adverse Events	Up to Day 9	Proportion of patients with AE(s) - Number of Subjects affected with Events
Primary	Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment	Up to Day 9	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
Secondary	Overall Assessment of the Study Medication by End of Study Patient Questionnaire	Up to Day 9	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)
Secondary	Overall Assessment of the Study Medication by End of Study Investigator Questionnaire	Up to Day 9	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)

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)	Up to Day 9	Safety Population: All patients enrolled in the study were included for safety analyses.	Number of Events	NUMBER
PRIMARY	Number of Subjects Affected With Adverse Events	Up to Day 9	Safety Population: All patients enrolled in the study were included for safety analyses.	Number of Subjects affected with Events	NUMBER
PRIMARY	Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment	Up to Day 9	Safety Population: All patients enrolled in the study were included for safety analyses.	Number of Events	NUMBER
SECONDARY	Overall Assessment of the Study Medication by End of Study Patient Questionnaire	Up to Day 9	Safety Population: All patients enrolled in the study were included for safety analyses.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Assessment of the Study Medication by End of Study Investigator Questionnaire	Up to Day 9	Safety Population: All patients enrolled in the study were included for safety analyses.	Number of investigator	NUMBER

Source ClinicalTrials.gov

Results by group71

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)	Mucinex™	Treatment Emergent Adverse Event (TEAE)	29	Number of Events
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)	Mucinex™	Serious TEAE	0	Number of Events
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)	Mucinex™	Non serious TEAE	29	Number of Events
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)	Mucinex™	Number of Events	29	Number of Events
Number of Subjects Affected With Adverse Events	Mucinex™		28	Number of Subjects affected with Events
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment	Mucinex™	Treatment Emergent Adverse Event (TEAE)	29	Number of Events
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment	Mucinex™	Serious TEAE	0	Number of Events
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment	Mucinex™	TEAE Leading to Withdrawal	0	Number of Events
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment	Mucinex™	TEAE by severity: Mild	29	Number of Events
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment	Mucinex™	TEAE by severity: Moderate	0	Number of Events

1 to 10 of 71Source ClinicalTrials.gov

See all 71 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mucinex™	552
Overall Study	COMPLETED	Mucinex™	550
Overall Study	NOT COMPLETED	Mucinex™	2

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Pain	Gastrointestinal disorders	Mucinex™	1	552	1
other	Abdominal Pain Upper	Gastrointestinal disorders	Mucinex™	4	552	4
other	Diarrhoea	Gastrointestinal disorders	Mucinex™	3	552	3
other	Dry Mouth	Gastrointestinal disorders	Mucinex™	1	552	1
other	Nausea	Gastrointestinal disorders	Mucinex™	2	552	2
other	Malaise	General disorders	Mucinex™	2	552	2
other	Pain	General disorders	Mucinex™	1	552	1
other	Dizziness	Nervous system disorders	Mucinex™	4	552	4
other	Headache	Nervous system disorders	Mucinex™	4	552	4
other	Anxiety	Psychiatric disorders	Mucinex™	3	552	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mucinex™	0	552
Total, other adverse events	Mucinex™	28	552
Total, serious adverse events	Mucinex™	0	552

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31632154	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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