Phase 4 Study - Mucinex D as Adjunct Therapy

Verified by: Adams Respiratory Therapeutics, February 2008
First Received: February 26, 2007 | Last Updated: February 5, 2008 | Phase: Phase 4 | Start Date: February 2007
Overall Status: Completed | Estimated Enrollment: 600
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The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection...

Brief Summary

Official Title: “A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Mucinex D as Adjunct Therapy to Antibiotic Treatment of Acute Respiratory Infection”

The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.

  • 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: Treatment
  • Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

  • Drug: Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)

Outcome Measures for this Clinical Trial

Primary Measures

  • The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
    • Time Frame: 7 days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Ages Eligible for Study: 18 to 75 years,
  • Genders Eligible for Study: Both
  • Adult patients presenting at the physician's office with symptoms diagnostic for acute respiratory infection, such as bronchitis or rhinosinusitis; with a clinical diagnosis of acute respiratory infection, meeting the physician's usual diagnostic criteria in practice for prescription of oral antibiotics.
  • The investigator will evaluate patients on a total of seven criteria for inclusion.

Exclusion Criteria:

  • Have chronic, recurring respiratory signs and symptoms, such as allergic rhinitis or chronic bronchitis, which, in the investigator's opinion, would confound interpretation of symptoms ratings for the acute respiratory infection;
  • The Investigator will evaluate patients on twelve additional criteria for exclusion.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Adams Respiratory Therapeutics Industry

Overall Clinical Trial Officials and Contacts

Helmut Albrecht, M.D. Study Chair Adams Respiratory Therapeutics  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00441246

Study ID Number: 2007-MUCD-001

ClinicalTrials.gov Identifier: NCT00441246

Health Authority: United States: Institutional Review Board

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