Trial · NCT01537081
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
NCT01537081, Phase 2, Phase 3, Completed, Reckitt Benckiser LLC; results first posted 2013-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections. Trials, record NCT01537081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01537081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
- NCT number
- NCT01537081
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 2,810 participants, actual
- Lead sponsor
- Reckitt Benckiser LLC
- Conditions
- Acute Upper Respiratory Tract Infection
- Interventions
- Mucinex, Immediate-release Guaifenesin, Placebo
- First posted
- 2012-02-22
- Last updated
- 2013-11-14
- Results first posted
- 2013-09-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 | 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, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms. |
| Primary | Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5 | 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, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms. |
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 | Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 | Day 4 | Modified Intent-To-Treat (i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 4 are included. | units on a scale | MEAN |
| PRIMARY | Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5 | Day 5 | Modified Intent-to-Treat(i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 5 are included. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 | Mucinex 2400 mg/Day | 12.96 | Standard Deviation 6.226 | units on a scale | |
| Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 | Immediate-release Guaifenesin 800 mg/Day | 12.87 | Standard Deviation 6.078 | units on a scale | |
| Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 | Placebo | 12.71 | Standard Deviation 5.828 | units on a scale | |
| Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5 | Mucinex 2400 mg/Day | 10.92 | Standard Deviation 6.448 | units on a scale | |
| Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5 | Immediate-release Guaifenesin 800 mg/Day | 10.80 | Standard Deviation 6.261 | units on a scale | |
| Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5 | Placebo | 11.05 | Standard Deviation 5.900 | units on a scale |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mucinex 2400 mg/Day | 1,123 | |
| Overall Study | STARTED | Immediate-release Guaifenesin 800 mg/Day | 1,124 | |
| Overall Study | STARTED | Placebo | 563 | |
| Overall Study | Safety Population | Mucinex 2400 mg/Day | 1,122 | |
| Overall Study | Safety Population | Immediate-release Guaifenesin 800 mg/Day | 1,122 | |
| Overall Study | Safety Population | Placebo | 561 | |
| Overall Study | Modified Intent to Treat Population | Mucinex 2400 mg/Day | 1,106 | |
| Overall Study | Modified Intent to Treat Population | Immediate-release Guaifenesin 800 mg/Day | 1,109 | |
| Overall Study | Modified Intent to Treat Population | Placebo | 556 | |
| Overall Study | COMPLETED | Mucinex 2400 mg/Day | 1,084 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events24
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 | Diarrhoea | Gastrointestinal disorders | Mucinex 2400 mg/Day | 21 | 1,122 | |
| other | Diarrhoea | Gastrointestinal disorders | Immediate-release Guaifenesin 800 mg/Day | 17 | 1,122 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 9 | 561 | |
| other | Nausea | Gastrointestinal disorders | Mucinex 2400 mg/Day | 18 | 1,122 | |
| other | Nausea | Gastrointestinal disorders | Immediate-release Guaifenesin 800 mg/Day | 19 | 1,122 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 561 | |
| other | Vomiting | Gastrointestinal disorders | Mucinex 2400 mg/Day | 7 | 1,122 | |
| other | Vomiting | Gastrointestinal disorders | Immediate-release Guaifenesin 800 mg/Day | 3 | 1,122 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 4 | 561 | |
| other | Pyrexia | General disorders | Mucinex 2400 mg/Day | 2 | 1,122 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mucinex 2400 mg/Day | ||
| Total, all-cause mortality | Immediate-release Guaifenesin 800 mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Mucinex 2400 mg/Day | 84 | 1,122 |
| Total, other adverse events | Immediate-release Guaifenesin 800 mg/Day | 85 | 1,122 |
| Total, other adverse events | Placebo | 41 | 561 |
| Total, serious adverse events | Mucinex 2400 mg/Day | 0 | 1,122 |
| Total, serious adverse events | Immediate-release Guaifenesin 800 mg/Day | 0 | 1,122 |
| Total, serious adverse events | Placebo | 1 | 561 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01537081
GET https://conductscience.org/api/trials/v1/NCT01537081/events?page=2