Mucinex Exploratory Cold Study

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2010

Interventions

  • Drug: guaifenesin (Mucinex)
    • bid 7 days
  • Drug: placebo
    • bid 7 days

Arms, Groups and Cohorts

  • Active Comparator: Mucinex
  • Placebo Comparator: placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Number of Patients With Adverse Events
    • Time Frame: 7 days
    • Total number of patients with adverse events that were possibly or probably related.

Participating in This Clinical Trial

Inclusion Criteria

  • common cold symptoms – meet symptom severity – females of child-bearing potential must have negative pregnancy test and use effective birth control Exclusion Criteria:

  • chronic respiratory conditions – significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder – pregnant or lactating – known malignancy – participation in any other clinical trial within 30 days of baseline – related to another enrolled patient or persons involved directly or indirectly with the conduct of this study

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Reckitt Benckiser Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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