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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01202279
First received: September 13, 2010
Last updated: October 4, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 1189
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
  • Guaifenesin
  • Pseudoephedrine
Placebo Comparator: Placebo
Placebo given bid with a full glass of water for 7 days
Device: Placebo
Placebo bid for 7 days
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT01202279

Locations
United States, Arizona
Clinical Research Advantage, Inc.
Mesa, Arizona, United States, 85203
United States, Delaware
Glasgow Family Practice
Newark, Delaware, United States, 19702
United States, New Jersey
Immedicenter
Bloomfield, New Jersey, United States, 07003
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

No publications provided

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01202279     History of Changes
Other Study ID Numbers: 2009-MUCD-001
Study First Received: September 13, 2010
Results First Received: April 4, 2011
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014