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Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (Wait and See)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202279
First Posted: September 15, 2010
Last Update Posted: August 21, 2017
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
The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo

Condition Intervention Phase
Acute Upper Respiratory Track Infection Drug: Guaifenesin Device: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of Mucinex D for Symptomatic Therapy in Patients With Acute Upper Respiratory Tract Who Seek Treatment

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • Antibiotic Sparing [ Time Frame: Day 7 ]
    Number of patients who received an antibiotic

  • Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). [ Time Frame: Baseline and 7 Days ]
    WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.


Enrollment: 1179
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mucinex D
Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days
Drug: Guaifenesin
1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
Other Names:
  • Mucinex D
  • Mucinex
  • Pseudoephedrine
Placebo Comparator: Placebo
Placebo given bid with a full glass of water for 7 days
Device: Placebo
Placebo bid for 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:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms diagnostic for an acute upper respiratory tract infection within the last 5 days

Exclusion Criteria:

  • patients who had chronic, recurring respiratory signs and symptoms due to conditions such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in the investigator's opinion, confounded interpretation of symptom ratings for the acute upper respiratory infection. Also excluded were patients with a fever greater than 101 degrees F.
  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): NCT01202279


  Show 24 Study Locations
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01202279     History of Changes
Other Study ID Numbers: 2009-MUCD-001
First Submitted: September 13, 2010
First Posted: September 15, 2010
Results First Submitted: April 4, 2011
Results First Posted: November 5, 2012
Last Update Posted: August 21, 2017
Last Verified: July 2017

Keywords provided by Reckitt Benckiser LLC:
Acute Upper Respiratory Track Infection Who Seek Treatment

Additional relevant MeSH terms:
Pseudoephedrine
Phenylpropanolamine
Ephedrine
Chlorpheniramine, phenylpropanolamine drug combination
Guaifenesin
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Expectorants
Adrenergic alpha-Agonists
Adrenergic Agonists
Appetite Depressants
Anti-Obesity Agents