Phase 4 Study - Mucinex D as Adjunct Therapy

February 5, 2008 updated by: Adams Respiratory Therapeutics

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214
    • California
      • Carmichael, California, United States, 95608
        • MedCenter, 6651 Madison Ave.
      • Torrance, California, United States, 90505
        • Torrance Clinical Research, 3640 Lomita Blfd #205
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Clinicos, LLC
      • Longmont, Colorado, United States, 80501
        • Longmont Clinic, P.C., 1925 W. Mountain View Ave.
      • Wheat Ridge, Colorado, United States, 80033
        • Front Range Clinical Research
    • Georgia
      • Dawsonville, Georgia, United States, 30534
        • Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175
    • Illinois
      • Morton, Illinois, United States, 61550
        • Koch Family Medicine, 81A E. Queenwood Rd.
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Welborn Clinic Gateway, 4233 Gateway Blvd
    • Kentucky
      • Erlanger, Kentucky, United States, 41018
        • Sterling Research Group, Ltd., 650 Sprucewood Lane
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Columbia Medical Practice, 3450 Knoll Dr. North #200C
      • Reisterstown, Maryland, United States, 21136
        • Clinical Associates, 750 Main St. #201
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • Milford Emergency Associates, Inc., 14 Asylum St.
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Michigan Institute of Medicine, 38525 Eight Mile Rd.
    • Nebraska
      • Broken Bow, Nebraska, United States, 68822
        • Central Nebraska Medical Clinic, PC, 145 Memorial Drive
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Immedicenter, 557 Broad St.
    • New York
      • Manlius, New York, United States, 13104
        • Central New York Clinical Research, RT 92, The Market Place
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A
    • Ohio
      • Akron, Ohio, United States, 44313
        • DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100
      • Canfield, Ohio, United States, 44406
        • DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL)
      • Columbus, Ohio, United States, 43207
        • Parsons Avenue Medical Clinic, 1493 Parsons Avenue
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave.
      • Harleysville, Pennsylvania, United States, 19438
        • Harleysville Medical Associates, 176 Main Street
      • Harleysville,, Pennsylvania, United States, 19438
        • Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120
      • Pittsburgh, Pennsylvania, United States, 15220
        • Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5
    • Texas
      • Austin, Texas, United States, 78749
        • MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive
      • Poth, Texas, United States, 78114
        • Apollo Research Institute, 117 Dilworth Plaza
    • Utah
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adams Respiratory Therapeutics

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 27, 2007

First Posted (ESTIMATE)

February 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2008

Last Update Submitted That Met QC Criteria

February 5, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-MUCD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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