A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies

NCT ID: NCT04162795

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2019-11-13

Brief Summary

In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. A questionnaire was used to collect the feedback from participants. The study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Loratadine chewable tablet

Participants received one dose of loratadine chewable tablet to chew completely before swallowing.

Group Type: EXPERIMENTAL

Loratadine (Claritin, BAY76-2211)

Intervention Type: DRUG

Chewable tablet, oral, single dose

Interventions

Loratadine (Claritin, BAY76-2211)

Chewable tablet, oral, single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female or male adults aged 18 to 65 years of age inclusive
• Were in good general health
• Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
• Agreed to not use antihistamine products 24 hours before and after the treatment
• Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing

Exclusion Criteria

• Individuals who had used oral/systemic medications 24 hours before the first administration of test product
• Individuals who used medications which might influence taste perception
• Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
• Women who were pregnant or thinking of becoming pregnant or were nursing
• Participants with congestion at the time of study visit
• Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day
• Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)
• History of alcohol or drug abuse
• History of hypersensitivity or allergic reactions to any ingredients in the test product
• Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties
• Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Focus Pointe Global

Teaneck, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21048

Identifier Type: -

Identifier Source: org_study_id