Who is sponsoring NCT00319995?

NCT00319995 is sponsored by Organon and Co.

What condition does NCT00319995 study?

NCT00319995 studies Rhinitis, Allergic, Seasonal.

What drugs are being tested in NCT00319995?

Interventions: loratadine; montelukast.

What is the status of NCT00319995?

NCT00319995 is currently COMPLETED.

Last reviewed 2024-08-15 · How we verify

Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)

NCT00319995 PHASE3 COMPLETED

This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.

Details

Lead sponsor	Organon and Co
Phase	PHASE3
Status	COMPLETED
Enrolment	1095
Start date	Wed Mar 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jun 28 2006 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Rhinitis, Allergic, Seasonal

Interventions

loratadine; montelukast