NCT01537081 is a Phase 2/Phase 3 clinical trial of Mucinex in Acute Upper Respiratory Tract Infection, sponsored by Reckitt Benckiser LLC.

Who is sponsoring NCT01537081?

NCT01537081 is sponsored by Reckitt Benckiser LLC.

What drugs are being tested in NCT01537081?

Interventions in NCT01537081: Mucinex, Immediate-release Guaifenesin, Placebo.

What condition does NCT01537081 study?

NCT01537081 studies Acute Upper Respiratory Tract Infection.

Is NCT01537081 still recruiting?

NCT01537081 is currently completed. Last updated 22 October 2013.

Are results published for NCT01537081?

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

Last reviewed 2013-10-22 · How we verify

NCT01537081

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

Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d) in the Treatment of Symptoms of Acute Upper Respiratory Tract Infections For 7 Days

Completed Phase 2/Phase 3 Results posted Last updated 22 October 2013

What this trial tests

Phase 2/Phase 3 trial testing Mucinex in Acute Upper Respiratory Tract Infection in 2,810 participants. Completed in 1 July 2012.

Timeline

1 September 2011

Primary endpoint
1 March 2012

1 July 2012

Quick facts

Lead sponsor	Reckitt Benckiser LLC
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	2,810
Start date	1 September 2011
Primary completion	1 March 2012
Estimated completion	1 July 2012
Sites	43 locations across United States

Drugs / interventions tested

Mucinex (guaifenesin) — full drug profile →
Immediate-release Guaifenesin — full drug profile →
Placebo

Conditions studied

Acute Upper Respiratory Tract Infection — all drugs for Acute Upper Respiratory Tract Infection →

Sponsor

Reckitt Benckiser LLC — full company profile →

Who can join

12 and older, any sex, with Acute Upper Respiratory Tract Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4
Time frame: Day 4
Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5
Time frame: Day 5
Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4

Sponsor's own description

The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Reckitt Benckiser LLC trials

Trials by the same sponsor.

NCT03725085 — Study to Evaluate the Safety and Tolerability of Mucinex™(Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets in the T · Phase 4 · completed
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 NCT01537081 (US National Library of Medicine, public domain)
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: 22 October 2013

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/NCT01537081.

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