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A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Lindus Health Limited
New York, New York, United States
Start Date
December 4, 2024
Primary Completion Date
February 14, 2025
Completion Date
February 14, 2025
Last Updated
February 20, 2026
244
ACTUAL participants
Robitussin Maximum Strength Cough and Chest Congestion DM
DRUG
Robitussin Maximum Strength Cough and Chest Congestion DM
DRUG
Robitussin Maximum Strength Nighttime Cough DM
DRUG
Lead Sponsor
HALEON
NCT05665244
NCT05989698
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07112144