Mucinex Exploratory Cold Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.

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Detailed Description

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Conditions

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Common Cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mucinex

Group Type ACTIVE_COMPARATOR

guaifenesin (Mucinex)

Intervention Type DRUG

bid 7 days

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

bid 7 days

Interventions

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guaifenesin (Mucinex)

bid 7 days

Intervention Type DRUG

placebo

bid 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* common cold symptoms
* meet symptom severity
* females of child-bearing potential must have negative pregnancy test and use effective birth control

Exclusion Criteria

* chronic respiratory conditions
* significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder
* pregnant or lactating
* known malignancy
* participation in any other clinical trial within 30 days of baseline
* related to another enrolled patient or persons involved directly or indirectly with the conduct of this study

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No