CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 261 enrolled
Drug / intervention
loratadine +2 moredrug
Likely dose
loratadine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00730912
NCT00730912Phase 4Completed
CompareCT.gov

Protocol for Post-approval Commitment Study of Loratadine for PPK Analysis in Japanese Pediatric and Adults Patients

Merck Sharp & Dohme LLC·interventional·Posted Aug 8, 2008·Updated Apr 13, 2017

In Brief

A Phase 4 clinical trial evaluating loratadine for Perennial Allergic Rhinitis. Completed, enrolled 261 participants.

Detailed Summary

This is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerennial Allergic Rhinitis
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2008
Enrollment StartJun 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.9 years ago

Interventions

loratadinedrug

Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks

loratadinedrug

loratadine 10 mg tablet once daily for 4 weeks

loratadinedrug

loratadine 10 mg tablet once daily for 4 weeks