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Phase 4 Study - Mucinex D as Adjunct Therapy

Primary Purpose

Acute Respiratory Infection, Bronchitis, Rhinosinusitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)
Sponsored by
Adams Respiratory Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Infection focused on measuring Acute Respiratory Infection, Bronchitis, Rhinosinusitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214
  • MedCenter, 6651 Madison Ave.
  • Torrance Clinical Research, 3640 Lomita Blfd #205
  • Clinicos, LLC
  • Longmont Clinic, P.C., 1925 W. Mountain View Ave.
  • Front Range Clinical Research
  • Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175
  • Koch Family Medicine, 81A E. Queenwood Rd.
  • Welborn Clinic Gateway, 4233 Gateway Blvd
  • Sterling Research Group, Ltd., 650 Sprucewood Lane
  • Columbia Medical Practice, 3450 Knoll Dr. North #200C
  • Clinical Associates, 750 Main St. #201
  • Milford Emergency Associates, Inc., 14 Asylum St.
  • Michigan Institute of Medicine, 38525 Eight Mile Rd.
  • Central Nebraska Medical Clinic, PC, 145 Memorial Drive
  • Immedicenter, 557 Broad St.
  • Central New York Clinical Research, RT 92, The Market Place
  • North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A
  • DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100
  • DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL)
  • Parsons Avenue Medical Clinic, 1493 Parsons Avenue
  • Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave.
  • Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120
  • Harleysville Medical Associates, 176 Main Street
  • Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5
  • MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive
  • Apollo Research Institute, 117 Dilworth Plaza
  • Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230

Outcomes

Primary Outcome 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.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2007
Last Updated
February 5, 2008
Sponsor
Adams Respiratory Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00441246
Brief Title
Phase 4 Study - Mucinex D as Adjunct Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Adams Respiratory Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection, Bronchitis, Rhinosinusitis
Keywords
Acute Respiratory Infection, Bronchitis, Rhinosinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Albrecht, M.D.
Organizational Affiliation
Adams Respiratory Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
MedCenter, 6651 Madison Ave.
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Torrance Clinical Research, 3640 Lomita Blfd #205
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Longmont Clinic, P.C., 1925 W. Mountain View Ave.
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Front Range Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534
Country
United States
Facility Name
Koch Family Medicine, 81A E. Queenwood Rd.
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550
Country
United States
Facility Name
Welborn Clinic Gateway, 4233 Gateway Blvd
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Sterling Research Group, Ltd., 650 Sprucewood Lane
City
Erlanger
State/Province
Kentucky
ZIP/Postal Code
41018
Country
United States
Facility Name
Columbia Medical Practice, 3450 Knoll Dr. North #200C
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Clinical Associates, 750 Main St. #201
City
Reisterstown
State/Province
Maryland
ZIP/Postal Code
21136
Country
United States
Facility Name
Milford Emergency Associates, Inc., 14 Asylum St.
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Michigan Institute of Medicine, 38525 Eight Mile Rd.
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Central Nebraska Medical Clinic, PC, 145 Memorial Drive
City
Broken Bow
State/Province
Nebraska
ZIP/Postal Code
68822
Country
United States
Facility Name
Immedicenter, 557 Broad St.
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Central New York Clinical Research, RT 92, The Market Place
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100
City
Akron
State/Province
Ohio
ZIP/Postal Code
44313
Country
United States
Facility Name
DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL)
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Facility Name
Parsons Avenue Medical Clinic, 1493 Parsons Avenue
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave.
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120
City
Harleysville,
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Harleysville Medical Associates, 176 Main Street
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Apollo Research Institute, 117 Dilworth Plaza
City
Poth
State/Province
Texas
ZIP/Postal Code
78114
Country
United States
Facility Name
Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States

12. IPD Sharing Statement

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Phase 4 Study - Mucinex D as Adjunct Therapy

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