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Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01537081
First received: February 16, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections.


Condition Intervention Phase
Acute Upper Respiratory Tract Infection
 Drug: Guaifenesin
Drug: IR Guaifenesin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d)in the Treatment of Symptoms of Acute Upper Respiratory Tract Infections For 7 Days

Resource links provided by NLM:

MedlinePlus related topics: Common Cold
U.S. FDA Resources

Further study details as provided by Reckitt Benckiser LLC:

Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mucinex and IR guaifenesin placebo
Two 600 mg Mucinex bi-layer tablets and one placebo matching 200 mg IR guaifenesin tablet.
 Drug: Guaifenesin
Two 600 mg Mucinex bi-layer tablets and one placebo matching the 200 mg IR guaifenesin tablet, every 12 hours for 7 days.
Active Comparator: IR guaifenesin and Mucinex placebo
One 200 mg IR guaifenesin tablet and two matching 600 mg Mucinex placebo tablets.
 Drug: IR Guaifenesin
One 200 mg IR guaifenesin tablet and two matching 600 mg Mucinex placebo tablets, every 6 (+/- 2) hours for 7 days.
Placebo Comparator: Mucinex placebo & IR guaifenesin placebo
Two matching 600 mg Mucinex placebo tablets combined with one matching 200 mg IR guaifenesin placebo tablet.
 Drug: Placebo
Two matching 600 mg Mucinex placebo tablets combined with one matching 200 mg IR guaifenesin placebo tablet, every (+/- 2) hours for 7 days.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Has developed cold symptoms within 3 days prior to dosing on Day 1.

Exclusion Criteria:

  1. Chronic illnesses.
  2. Febrile illness > 101 F within 7 days prior to Day 1,
  3. Pregnant.
  4. Known current malignancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537081

  Show 43 Study Locations
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

No publications provided

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01537081     History of Changes
Other Study ID Numbers: 2011-MUC-04
Study First Received: February 16, 2012
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

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
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 May 19, 2013