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

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ClinicalTrials.gov Identifier: NCT01202279
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : November 5, 2012
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Upper Respiratory Track Infection Drug: Guaifenesin Device: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1179 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01202279     History of Changes
Other Study ID Numbers: 2009-MUCD-001
First Posted: September 15, 2010    Key Record Dates
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