Who is sponsoring NCT00088491?

NCT00088491 is sponsored by Eli Lilly and Company.

What condition does NCT00088491 study?

NCT00088491 studies Schizophrenic Disorders.

What drugs are being tested in NCT00088491?

Interventions: Intramuscular Olanzapine Depot, Oral Olanzapine.

What is the status of NCT00088491?

NCT00088491 is currently COMPLETED.

Last reviewed 2007-06-20 · How we verify

A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia

NCT00088491 Phase 3 COMPLETED

This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine depot works compared to oral olanzapine; evaluate the safety and tolerability of IM olanzapine depot compared to oral olanzapine; evaluate different doses of IM olanzapine depot; and determine the blood levels of IM olanzapine depot in patients at different points in time after an injection.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	COMPLETED
Enrolment	1205
Start date	2004-06
Completion	2006-10

Conditions

Schizophrenic Disorders

Interventions

Intramuscular Olanzapine Depot
Oral Olanzapine

Primary outcomes

Determine comparative efficacy in patients with schizophrenia of non-inferiority of IM olanzapine depot high and low doses versus oral olanzapine based on exacerbation rates after 6 months of maintenance treatment
Determine comparative efficacy in patients with schizophrenia of superiority of IM olanzapine depot low, med and high doses versus very low dose based on time to exacerbation of symptoms of schizophrenia

Countries

Finland, Turkey (Türkiye)