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This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucinex | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| guaifenesin (Mucinex) | Drug | bid 7 days |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's End of Study Assessment of Treatment | Yes the investigator would use this treatment for cold symptoms in the future. | 7 days |
| 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. | 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. | Baseline and Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events | Total number of patients with adverse events that were possibly or probably related. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pioneer Clinical Research | Bellevue | Nebraska | 68005 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24003241 | Derived | Hoffer-Schaefer A, Rozycki HJ, Yopp MA, Rubin BK. Guaifenesin has no effect on sputum volume or sputum properties in adolescents and adults with acute respiratory tract infections. Respir Care. 2014 May;59(5):631-6. doi: 10.4187/respcare.02640. Epub 2013 Sep 3. | |
| 23270519 | Derived | Albrecht H, Vernon M, Solomon G. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms. Respir Res. 2012 Dec 27;13(1):118. doi: 10.1186/1465-9921-13-118. |
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Participants screened over 2 day period who suffer from an acute respiratory tract infection.
Participants were recruited from waiting rooms of health care providers/clinics between December 2009 and March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mucinex | 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS |
| FG001 | Placebo | 2 TABLETS EVERY 12 HOURS FOR 7 DAYS |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mucinex | 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS |
| BG001 | Placebo | 2 TABLETS EVERY 12 HOURS FOR 7 DAYS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator's End of Study Assessment of Treatment | Yes the investigator would use this treatment for cold symptoms in the future. | 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. | Posted | Number | participants | 7 days |
|
Adverse event data was collected through the treatment period. All patients who received at least 1 dose of study medication were included in the safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mucinex | 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arrhythmia supraventricular | Cardiac disorders | MedDRA (12.1) | SAE considered not related to study medication. All SAEs in this study were for one patient and related to one event that occurred 17 days prior to treatment start date. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Clark | Reckitt Benckiser | 855.966.5483 | ClinicalRequests@rb.com |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D006140 | Guaifenesin |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010647 |
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| Drug |
bid 7 days |
|
| Lost to Follow-up |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Number of Patients With Adverse Events | Total number of patients with adverse events that were possibly or probably related. | All participants who received study medication, excluding participants who later returned all the dispensed study medication to the site unused. | Posted | Number | participants | 7 days |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 4 |
|
|
|
|
| 1 |
| 188 |
| 0 |
| 188 |
| EG001 | Placebo | 2 TABLETS EVERY 12 HOURS FOR 7 DAYS | 0 | 189 | 0 | 189 |
|
| Endocarditis | Infections and infestations | MedDRA (12.1) | SAE considered not related to study medication. All SAEs in this study were for one patient and related to one event that occurred 17 days prior to treatment start date. |
|
| Lymphatic duct injury | Injury, poisoning and procedural complications | MedDRA (12.1) | SAE considered not related to study medication. All SAEs in this study were for one patient and related to one event that occurred 17 days prior to treatment start date. |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | SAE considered not related to study medication. All SAEs in this study were for one patient and related to one event that occurred 17 days prior to treatment start date. |
|
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| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |