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Mucinex Exploratory Cold Study

NCT ID: NCT01046136

Last Updated: 2020-12-30

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.

Detailed Description

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Conditions

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Common Cold

Keywords

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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

Sponsors

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Reckitt Benckiser Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pioneer Clinical Research

Bellevue, Nebraska, United States

Site Status

Countries

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United States

References

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Hoffer-Schaefer A, Rozycki HJ, Yopp MA, Rubin BK. Guaifenesin has no effect on sputum volume or sputum properties in adolescents and adults with acute respiratory tract infections. Respir Care. 2014 May;59(5):631-6. doi: 10.4187/respcare.02640. Epub 2013 Sep 3.

Reference Type DERIVED
PMID: 24003241 (View on PubMed)

Albrecht H, Vernon M, Solomon G. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms. Respir Res. 2012 Dec 27;13(1):118. doi: 10.1186/1465-9921-13-118.

Reference Type DERIVED
PMID: 23270519 (View on PubMed)

Other Identifiers

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2009-MUC-03

Identifier Type: -

Identifier Source: org_study_id