NCT03725085

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

An Open Label, Multicentric 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: Reckitt Benckiser LLC · Industry
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Mucinex™ extended-release (SE)	2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)

Timeline

• Start date: 2015-01-24
• Primary completion: 2015-10-16
• Completion: 2015-10-16
• First posted: 2018-10-30
• Last updated: 2019-03-19
• Results posted: 2019-03-19

Regulatory

• FDA-regulated drug study