Skip to main content
OpenTrials
Completed

NCT Number: NCT00780403

Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)

The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent
  • 6-11 years old, either sex, either race
  • If female, subject to be premenarcheal
  • Willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
  • Free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
  • Able to adhere to the dosing and visit schedules

Exclusion criteria

  • If female, subject who was pregnant, intended to become pregnant during the study or nursing.
  • Subject had used any investigational product within 30 days prior to enrollment.
  • Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.
  • Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).
  • Subject was participating in any other clinical study(ies).
  • Subject was part of the staff or a family member of the staff personnel directly involved with this study.
  • Subject was allergic to or has sensitivity to the study drug or its excipients.
  • Subject had a history of allergic reaction to prescription and/or over the counter (OTC) medications and/or food products.
  • Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.7.
  • Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.

Treatment and study plan

desloratadine

Drug

desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day

Other names: SCH 034117

Zyrtec® (cetirizine)

Drug

Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day

Primary outcomes

  1. Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.

    Time frame: Following the second dose (8-10 minutes after the first dose)

    A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Oct 27, 2008
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.