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Completed

NCT Number: NCT01046136

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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pioneer Clinical Research

Bellevue, Nebraska, 68005, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

guaifenesin (Mucinex)

Drug

bid 7 days

Placebo

Drug

bid 7 days

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. Number of Patients With Adverse Events

    Time frame: 7 days

    Total number of patients with adverse events that were possibly or probably related.

Sponsors and collaborators

Lead sponsor

Reckitt Benckiser Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
First posted
Jan 11, 2010
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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