NCT03725085 is a Phase 4 clinical trial of Mucinex™ extended-release (SE) in Healthy Subjects, sponsored by Reckitt Benckiser LLC.

Who is sponsoring NCT03725085?

NCT03725085 is sponsored by Reckitt Benckiser LLC.

What drugs are being tested in NCT03725085?

Interventions in NCT03725085: Mucinex™ extended-release (SE).

What condition does NCT03725085 study?

NCT03725085 studies Healthy Subjects.

Is NCT03725085 still recruiting?

NCT03725085 is currently completed. Last updated 19 March 2019.

Are results published for NCT03725085?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-19 · How we verify

NCT03725085

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 19 March 2019

What this trial tests

Phase 4 trial testing Mucinex™ extended-release (SE) in Healthy Subjects in 552 participants. Completed in 16 October 2015.

Timeline

24 January 2015

Primary endpoint
16 October 2015

16 October 2015

Quick facts

Lead sponsor	Reckitt Benckiser LLC
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	552
Start date	24 January 2015
Primary completion	16 October 2015
Estimated completion	16 October 2015

Drugs / interventions tested

Mucinex™ extended-release (SE)

Conditions studied

Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Reckitt Benckiser LLC — full company profile →

Who can join

Adults 18 to 82, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s) Primary · 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

Treatment Emergent Adverse Event (TEAE)

Group	Value	95% CI
Mucinex™	29

Serious TEAE

Group	Value	95% CI
Mucinex™	0

Non serious TEAE

Group	Value	95% CI
Mucinex™	29

Number of Events

Group	Value	95% CI
Mucinex™	29

Number of Subjects Affected With Adverse Events Primary · Up to Day 9

Proportion of patients with AE(s) - Number of Subjects affected with Events

Group	Value	95% CI
Mucinex™	28

Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment Primary · 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

Treatment Emergent Adverse Event (TEAE)

Group	Value	95% CI
Mucinex™	29

Serious TEAE

Group	Value	95% CI
Mucinex™	0

TEAE Leading to Withdrawal

Group	Value	95% CI
Mucinex™	0

TEAE by severity: Mild

Group	Value	95% CI
Mucinex™	29

TEAE by severity: Moderate

Group	Value	95% CI
Mucinex™	0

TEAE by severity: Severe

Group	Value	95% CI
Mucinex™	0

Relationship to IMP - Certain

Group	Value	95% CI
Mucinex™	0

Relationship to IMP - Probable

Group	Value	95% CI
Mucinex™	5

Overall Assessment of the Study Medication by End of Study Patient Questionnaire Secondary · 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)

Improvement of Chest Congestion: Very Satisfied

Group	Value	95% CI
Mucinex™	95

Improvement of Chest Congestion: Satisfied

Group	Value	95% CI
Mucinex™	379

Improvement of Chest Congestion: Mostly Satisfied

Group	Value	95% CI
Mucinex™	67

Improvement of Chest Congestion: Not Satisfied

Group	Value	95% CI
Mucinex™	9

Improvement of Chest Congestion: Missing

Group	Value	95% CI
Mucinex™	2

Improvement of Chesty Cough: Very Satisfied

Group	Value	95% CI
Mucinex™	97

Improvement of Chesty Cough: Satisfied

Group	Value	95% CI
Mucinex™	372

Improvement of Chesty Cough: Mostly Satisfied

Group	Value	95% CI
Mucinex™	73

Overall Assessment of the Study Medication by End of Study Investigator Questionnaire Secondary · 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)

Treatment outcome with URTIs taking Mucinex: MS

Group	Value	95% CI
Mucinex™	2

Treatment outcome with URTIs taking Mucinex: Stfd

Group	Value	95% CI
Mucinex™	5

Treatment outcome with URTIs taking Mucinex: VS

Group	Value	95% CI
Mucinex™	2

Patient satisfaction with the treatment of CC: NS

Group	Value	95% CI
Mucinex™	1

Patient satisfaction with the treatment of CC:Stfd

Group	Value	95% CI
Mucinex™	5

Patient satisfaction with the treatment of CC: VS

Group	Value	95% CI
Mucinex™	3

Patient satisfaction with the treatment of CCO: MS

Group	Value	95% CI
Mucinex™	1

Patient satisfaction with treatment of CCO:Stfd

Group	Value	95% CI
Mucinex™	5

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to End of Study (Day 9). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mucinex™

Serious: 0/552 (0%)

Deaths: 0/552

Other adverse events (12 terms — click to expand)

Reaction	System	Mucinex™
Abdominal Pain Upper	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Diarrhoea	Gastrointestinal disorders	—
Anxiety	Psychiatric disorders	—
Nausea	Gastrointestinal disorders	—
Malaise	General disorders	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Abdominal Pain	Gastrointestinal disorders	—
Dry Mouth	Gastrointestinal disorders	—
Pain	General disorders	—

Data from ClinicalTrials.gov NCT03725085 adverse events section.

Sponsor's own description

This was an open label, multicentric, non-comparative, single arm prospective post marketing surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to URTI. Symptomatic patients who visited the outpatient department of hospitals and clinics or general physicians and had agreed to participate in this study were screened and enrolled into the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety And Tolerability Of Extended-Release Guaifenesin In Patients With Cough, Thickened Mucus And Chest Congestion Associated With Upper Respiratory Tract Infection.
Tripathi S, Nikhare A, Sharma G, Shea T, et al · · 2019 · cited 4× · PMID 31632154 · DOI 10.2147/dhps.s222109

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Other Reckitt Benckiser LLC trials

Trials by the same sponsor.

NCT03649750 — Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted · Phase 1 · completed
NCT03633487 — Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet · Phase 1 · completed
NCT03633448 — Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents · Phase 1 · completed
NCT03642873 — Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03725085 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Reckitt Benckiser LLC
Last refreshed: 19 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03725085.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing