A Phase 4 interventional study of Guaifenesin and Placebo in Acute Upper Respiratory Track Infection, sponsored by Reckitt Benckiser Inc.. Completed at 24 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-12-30.
Sponsored by Reckitt Benckiser Inc. · Phase 4, Interventional, and Prevention
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
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,179 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Reckitt Benckiser Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days
Drug: Guaifenesin
Placebo given bid with a full glass of water for 7 days
Device: Placebo
1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
Also known as: Mucinex D, Mucinex, Pseudoephedrine
Placebo bid for 7 days
Antibiotic Sparing
Number of patients who received an antibiotic
Time frame: Day 7
Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).
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.
Time frame: Baseline and 7 Days
Recruitment took place October 2009 through April 2010. Advertising was not allowed for this study. Patients were seen by a Health Care Provider(HCP) and must have been seeking treatment for symptoms diagnostic for an acute upper respiratory tract infection.
| Milestone | Mucinex D | Placebo |
|---|---|---|
| Started | 591 | 588 |
| Completed | 554 | 561 |
| Not completed | 37 | 27 |
| Withdrew: Adverse event | 8 | 6 |
| Withdrew: Withdrawal by subject | 13 | 10 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Lost to follow-up | 10 | 7 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Study compliance | 5 | 2 |
Number of patients who received an antibiotic
| Participants | Mucinex D | Placebo |
|---|---|---|
| Antibiotic Sparing | 89 | 121 |
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.
| units on a scale | Mucinex D | Placebo |
|---|---|---|
| Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). | -14.2 ± 7.71 | -13.4 ± 7.99 |
Collected over Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mucinex D | — | 0/593 (0%) | 37/593 (6.2%) |
| Placebo | — | 0/591 (0%) | 21/591 (3.6%) |
| Event | Mucinex D | Placebo |
|---|---|---|
| InsomniaPsychiatric disorders | 17/593 | 1/591 |
| HeadacheNervous system disorders | 7/593 | 14/591 |
| NervousnessPsychiatric disorders | 7/593 | 4/591 |
| DizzinessNervous system disorders | 6/593 | 2/591 |
| Age, Categorical(Participants) | Mucinex D | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 575 | 575 | 1150 |
| >=65 years | 16 | 13 | 29 |
| Age, Continuous(years) | Mucinex D | Placebo | Total |
|---|---|---|---|
| Mean | 37.4 ± 13.7 | 38.8 ± 13.7 | 38.1 ± 13.7 |
| Sex: Female, Male(Participants) | Mucinex D | Placebo | Total |
|---|---|---|---|
| Female | 395 | 404 | 799 |
| Male | 196 | 184 | 380 |
| Region of Enrollment(participants) | Mucinex D | Placebo | Total |
|---|---|---|---|
| United States | 591 | 588 | 1179 |
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Reckitt Benckiser Inc.