Mucinex Exploratory Cold Study
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|ClinicalTrials.gov Identifier: NCT01046136|
Recruitment Status : Completed
First Posted : January 11, 2010
Results First Posted : August 24, 2012
Last Update Posted : August 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Common Cold||Drug: guaifenesin (Mucinex) Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||378 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||March 2010|
|Active Comparator: Mucinex||
Drug: guaifenesin (Mucinex)
bid 7 days
|Placebo Comparator: placebo||
bid 7 days
- Investigator's End of Study Assessment of Treatment [ Time Frame: 7 days ]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 ]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 ]Total number of patients with adverse events that were possibly or probably related.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046136
|United States, Nebraska|
|Pioneer Clinical Research|
|Bellevue, Nebraska, United States, 68005|