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Study to Evaluate the Safety and Tolerability of Mucinex™(Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest Congestion

NCT03725085 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2019-03-19

Study results available
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Summary

This was an open label, multicentric, non-comparative, single arm prospective post marketing surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to URTI. Symptomatic patients who visited the outpatient department of hospitals and clinics or general physicians and had agreed to participate in this study were screened and enrolled into the study.

Conditions

  • Healthy Subjects

Interventions

DRUG

Mucinex™ extended-release (SE)

2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)

Sponsors & Collaborators

  • Reckitt Benckiser LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-24
Primary Completion
2015-10-16
Completion
2015-10-16
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03725085 on ClinicalTrials.gov