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

NCT01202279 ↗

Phase 4 Completed 1179 enrolled Reckitt Benckiser Inc.

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo

Timeline

Start: 2009-10
Primary completion: 2010-04
Completion: 2010-07

Outcome

Met primary endpoint

registry NUMBER Mucinex D: 89 Participants NUMBER Placebo: 121 Participants analysis (unspecified test); Mucinex D vs Placebo; p = 0.025; Fisher Exact NCT01202279 ↗

registry MEAN Mucinex D: -14.2 (Standard Deviation 7.71) units on a scale MEAN Placebo: -13.4 (Standard Deviation 7.99) units on a scale analysis (unspecified test); Mucinex D vs Placebo; p = 0.022; ANCOVA NCT01202279 ↗

Publications

Septimus EJ, Albrecht HH, Solomon G, Shea T, Guenin EP. Extended-Release Guaifenesin/Pseudoephedrine Hydrochloride for Symptom Relief in Support of a Wait-and-See Approach for the Treatment of Acute Upper Respiratory Tract Infections: A Randomized, Double-Blind, Placebo-Controlled Study. Curr Ther Res Clin Exp. 2017 Apr 28;84:54-61. doi: 10.1016/j.curtheres.2017.04.004. eCollection 2017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Guaifenesin	Small molecule	1200 mg	—
Subject	Pseudoephedrine	Small molecule	120 mg	—