Mucinex Exploratory Cold Study
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days|
- Investigator's End of Study Assessment of Treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]Yes the investigator would use this treatment for cold symptoms in the future.
- 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. [ Time Frame: Baseline and Day 4 ] [ Designated as safety issue: No ]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.
- Number of Patients With Adverse Events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]Total number of patients with adverse events that were possibly or probably related.
|Study Start Date:||December 2009|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Mucinex||
Drug: guaifenesin (Mucinex)
bid 7 days
|Placebo Comparator: placebo||
bid 7 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046136
|United States, Nebraska|
|Pioneer Clinical Research|
|Bellevue, Nebraska, United States, 68005|