Phase 4 Study - Mucinex D as Adjunct Therapy

NCT ID: NCT00441246

Last Updated: 2008-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Infection Bronchitis Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adams Respiratory Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Adams RT

Principal Investigators

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Helmut Albrecht, M.D.

Role: STUDY_CHAIR

Adams Respiratory Therapeutics

Locations

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Alabama Clinical Therapuetics, LLC, 52 Medical Park East Drive, Suite 214

Birmingham, Alabama, United States

Site Status

MedCenter, 6651 Madison Ave.

Carmichael, California, United States

Site Status

Torrance Clinical Research, 3640 Lomita Blfd #205

Torrance, California, United States

Site Status

Clinicos, LLC

Colorado Springs, Colorado, United States

Site Status

Longmont Clinic, P.C., 1925 W. Mountain View Ave.

Longmont, Colorado, United States

Site Status

Front Range Clinical Research

Wheat Ridge, Colorado, United States

Site Status

Dawsonville Family Medicine Clinical Trials, 5983 Hwy, 53E. Ste 175

Dawsonville, Georgia, United States

Site Status

Koch Family Medicine, 81A E. Queenwood Rd.

Morton, Illinois, United States

Site Status

Welborn Clinic Gateway, 4233 Gateway Blvd

Newburgh, Indiana, United States

Site Status

Sterling Research Group, Ltd., 650 Sprucewood Lane

Erlanger, Kentucky, United States

Site Status

Columbia Medical Practice, 3450 Knoll Dr. North #200C

Columbia, Maryland, United States

Site Status

Clinical Associates, 750 Main St. #201

Reisterstown, Maryland, United States

Site Status

Milford Emergency Associates, Inc., 14 Asylum St.

Milford, Massachusetts, United States

Site Status

Michigan Institute of Medicine, 38525 Eight Mile Rd.

Livonia, Michigan, United States

Site Status

Central Nebraska Medical Clinic, PC, 145 Memorial Drive

Broken Bow, Nebraska, United States

Site Status

Immedicenter, 557 Broad St.

Bloomfield, New Jersey, United States

Site Status

Central New York Clinical Research, RT 92, The Market Place

Manlius, New York, United States

Site Status

North Carolina Clinical Research, 4301 Lake Boone Trail, Ste 309-A

Raleigh, North Carolina, United States

Site Status

DayStar Clinical Research, Inc., 880 Mull Ave., Suite 100

Akron, Ohio, United States

Site Status

DataPharm, Inc., 6715 Tippecanoe Rd., Bldg E (LL)

Canfield, Ohio, United States

Site Status

Parsons Avenue Medical Clinic, 1493 Parsons Avenue

Columbus, Ohio, United States

Site Status

Blair Medical Associates, Inc., Station Medical Center, 1414 Ninth Ave.

Altoona, Pennsylvania, United States

Site Status

Harleysville Medical Associates, 176 Main Street

Harleysville, Pennsylvania, United States

Site Status

Lederach Family Medicine, PC, 658 Harleysville Pike, Suite 120

Harleysville, Pennsylvania, United States

Site Status

Greentree Medical Associates, 651 Holiday Drive, Foster Plaza Bldg #5

Pittsburgh, Pennsylvania, United States

Site Status

MetaClin Research, Inc., 6012 West William Cannon Drive, 6012 West William Cannon Drive

Austin, Texas, United States

Site Status

Apollo Research Institute, 117 Dilworth Plaza

Poth, Texas, United States

Site Status

Advanced Clinical Research, Inc., 3590 West 9000 South, Suite 230

West Jordan, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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2007-MUCD-001

Identifier Type: -

Identifier Source: org_study_id

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