Trial · NCT01202279

Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI

NCT01202279, Phase 4, Completed, Reckitt Benckiser Inc.; results first posted 2012-11-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI. Trials, record NCT01202279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01202279

On this page

Trial

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

Title: Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
NCT number: NCT01202279
Status: Completed
Phases: Phase 4
Enrollment: 1,179 participants, actual
Lead sponsor: Reckitt Benckiser Inc.
Conditions: Acute Upper Respiratory Track Infection
Interventions: Guaifenesin, Placebo
First posted: 2010-09-15
Last updated: 2020-12-30
Results first posted: 2012-11-05

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Antibiotic Sparing	Day 7	Number of patients who received an antibiotic
Primary	Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).	Baseline and 7 Days	WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Antibiotic Sparing	Day 7	Per Protocol Population using Fishers Exact Test.	Participants	NUMBER
PRIMARY	Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).	Baseline and 7 Days		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Antibiotic Sparing	Mucinex D	89		Participants
Antibiotic Sparing	Placebo	121		Participants
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).	Mucinex D	-14.2	Standard Deviation 7.71	units on a scale
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).	Placebo	-13.4	Standard Deviation 7.99	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Mucinex D	591
Overall Study	STARTED	Placebo	588
Overall Study	COMPLETED	Mucinex D	554
Overall Study	COMPLETED	Placebo	561
Overall Study	NOT COMPLETED	Mucinex D	37
Overall Study	NOT COMPLETED	Placebo	27

Source ClinicalTrials.gov

Adverse events8

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	Nervousness	Psychiatric disorders	Mucinex D	7	593	7
other	Nervousness	Psychiatric disorders	Placebo	4	591	4
other	Insomnia	Psychiatric disorders	Mucinex D	17	593	18
other	Insomnia	Psychiatric disorders	Placebo	1	591	1
other	Headache	Nervous system disorders	Mucinex D	7	593	13
other	Headache	Nervous system disorders	Placebo	14	591	21
other	Dizziness	Nervous system disorders	Mucinex D	6	593	6
other	Dizziness	Nervous system disorders	Placebo	2	591	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mucinex D
Total, all-cause mortality	Placebo
Total, other adverse events	Mucinex D	37	593
Total, other adverse events	Placebo	21	591
Total, serious adverse events	Mucinex D	0	593
Total, serious adverse events	Placebo	0	591

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28761581	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 comparisons2

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

Comparison	Source
Mucinex D vs Placebo: Antibiotic Sparing	Trial comparisons
Mucinex D vs Placebo: serious adverse events	Trial comparisons

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.

GET https://conductscience.org/api/trials/v1/NCT01202279

GET https://conductscience.org/api/trials/v1/NCT01202279/registered

API reference For AI assistants