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Mucinex Exploratory Cold Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046136
First Posted: January 11, 2010
Last Update Posted: August 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Reckitt Benckiser LLC
  Purpose
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.

Condition Intervention Phase
Common Cold Drug: guaifenesin (Mucinex) Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

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


Enrollment: 378
Study Start Date: December 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mucinex Drug: guaifenesin (Mucinex)
bid 7 days
Placebo Comparator: placebo Drug: placebo
bid 7 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Nebraska
Pioneer Clinical Research
Bellevue, Nebraska, United States, 68005
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01046136     History of Changes
Other Study ID Numbers: 2009-MUC-03
First Submitted: January 7, 2010
First Posted: January 11, 2010
Results First Submitted: March 3, 2011
Results First Posted: August 24, 2012
Last Update Posted: August 27, 2012
Last Verified: August 2012

Keywords provided by Reckitt Benckiser LLC:
common cold

Additional relevant MeSH terms:
Respiratory Tract Infections
Common Cold
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents