NCT06716645

A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Real-World Evidence study is to generate real world data from participants with cough associated with the common cold, evaluating the effects in two arms with commercially available cough syrups on health-related quality of life (QoL). Arm 1 includes one cough syrup (which can be used day or night) and Arm 2 includes the daytime cough syrup and a nighttime cough syrup.

Detailed description

This is a longitudinal, randomized, decentralized, open-label study evaluating the effect on QoL factors in participants with cough associated with the common cold in two arms using Robitussin Maximum Strength in a real-world setting. A sufficient number of adult participants (approximately 372) with symptoms of common cold will be screened for eligibility. The study expects to enroll approximately 260 eligible participants with a total of 200 participants expected to complete the study, approximately 100 in each study group. Participants will be randomized into one of two study groups (at a 1:1 ratio). Participants will be recruited through targeted advertising on social media channels and participants will not be required to physically attend any on-site visits.

Conditions

• Common Cold
• Cough

Interventions

Type	Name	Description
DRUG	Robitussin Maximum Strength Cough and Chest Congestion DM	Dextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg
DRUG	Robitussin Maximum Strength Cough and Chest Congestion DM	Dextromethorphan Hydrobromide, USP 20 mg and Guaifenesin, USP 400 mg
DRUG	Robitussin Maximum Strength Nighttime Cough DM	Dextromethorphan Hydrobromide, USP 30 mg and Doxylamine Succinate, USP 12.5 mg

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-02-14
• Completion: 2025-02-14
• First posted: 2024-12-04
• Last updated: 2026-02-20
• Results posted: 2026-02-20

Locations

1 site across 1 country: United States