Trial · NCT01046136
Mucinex Exploratory Cold Study
NCT01046136, Phase 2, Completed, Reckitt Benckiser Inc.; results first posted 2012-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mucinex Exploratory Cold Study. Trials, record NCT01046136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01046136
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mucinex Exploratory Cold Study
- NCT number
- NCT01046136
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 378 participants, actual
- Lead sponsor
- Reckitt Benckiser Inc.
- Conditions
- Common Cold
- Interventions
- guaifenesin (Mucinex), placebo
- First posted
- 2010-01-11
- Last updated
- 2020-12-30
- Results first posted
- 2012-08-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator's End of Study Assessment of Treatment | 7 days | Yes the investigator would use this treatment for cold symptoms in the future. |
| Primary | Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. | Baseline and Day 4 | Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough. |
| Secondary | Number of Patients With Adverse Events | 7 days | Total number of patients with adverse events that were possibly or probably related. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator's End of Study Assessment of Treatment | 7 days | MITT defined as all participants receiving at least 1 dose of study medication and had 1 or more efficacy assessment after Baseline. Last observation carried forward method was applied to missing post baseline measurement in the analyses of the MITT population. | participants | NUMBER |
| SECONDARY | Number of Patients With Adverse Events | 7 days | All participants who received study medication, excluding participants who later returned all the dispensed study medication to the site unused. | participants | NUMBER |
| PRIMARY | Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. | Baseline and Day 4 | 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 |
|---|---|---|---|---|---|
| Investigator's End of Study Assessment of Treatment | Mucinex | 163 | participants | ||
| Investigator's End of Study Assessment of Treatment | Placebo | 149 | participants | ||
| Number of Patients With Adverse Events | Mucinex | 12 | participants | ||
| Number of Patients With Adverse Events | Placebo | 6 | participants | ||
| Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. | Mucinex | -1.1 | Standard Deviation 0.14 | units on a scale | |
| Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough. | Placebo | -0.9 | Standard Deviation 0.14 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mucinex | 188 | |
| Overall Study | STARTED | Placebo | 190 | |
| Overall Study | COMPLETED | Mucinex | 184 | |
| Overall Study | COMPLETED | Placebo | 182 | |
| Overall Study | NOT COMPLETED | Mucinex | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
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 |
|---|---|---|---|---|---|---|
| serious | arrhythmia supraventricular | Cardiac disorders | Mucinex | 1 | 188 | 1 |
| serious | arrhythmia supraventricular | Cardiac disorders | Placebo | 0 | 189 | 0 |
| serious | Endocarditis | Infections and infestations | Mucinex | 1 | 188 | 1 |
| serious | Endocarditis | Infections and infestations | Placebo | 0 | 189 | 0 |
| serious | Lymphatic duct injury | Injury, poisoning and procedural complications | Mucinex | 1 | 188 | 1 |
| serious | Lymphatic duct injury | Injury, poisoning and procedural complications | Placebo | 0 | 189 | 0 |
| serious | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Mucinex | 1 | 188 | 1 |
| serious | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 189 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mucinex | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Mucinex | 0 | 188 |
| Total, other adverse events | Placebo | 0 | 189 |
| Total, serious adverse events | Mucinex | 1 | 188 |
| Total, serious adverse events | Placebo | 0 | 189 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mucinex vs Placebo: Investigator's End of Study Assessment of Treatment | Trial comparisons |
| Mucinex vs Placebo: Number of Patients With Adverse Events | Trial comparisons |
| Mucinex 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.
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/NCT01046136
GET https://conductscience.org/api/trials/v1/NCT01046136/registered