drugset / Trial / NCT00249223

A Comparison of the Effectiveness and Safety of Injectable Risperidone With That of Risperidone Tablets in the Treatment of Patients With Chronic Schizophrenia

NCT00249223 ↗

Phase 3 Completed 641 enrolled Janssen Pharmaceutica N.V., Belgium
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary purpose of the study is to show that treatment with an injectable formulation of risperidone is not less effective than and has a similar safety profile to risperidone tablets in patients with chronic schizophrenia.

Timeline

Start
2000-01
Primary completion
—
Completion
2000-12

Outcome

Met primary endpoint

paper According to a noninferiority analysis, the two treatments showed comparable efficacy in total PANSS scores over the short-term. PMID 15572280 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 25 mg —
Subject Risperidone Other / unclassified 50 mg —
Subject Risperidone Other / unclassified 75 mg —

Indications