Mucinex Exploratory Cold Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01046136
First received: January 7, 2010
Last updated: August 24, 2012
Last verified: August 2012
  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: 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

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 ] [ 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046136

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

No publications provided by Reckitt Benckiser LLC

Additional 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
Study First Received: January 7, 2010
Results First Received: March 3, 2011
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Reckitt Benckiser LLC:
common cold

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

ClinicalTrials.gov processed this record on August 19, 2014