CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Asenapine 3x5mg followed by 1x15mg +1 moredrug
Likely dose
Asenapine 3x5mg followed by 1x15mg 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/NCT01101464
NCT01101464Phase 2Completed
CompareCT.gov

A Single-center, Open-label, 2-way Crossover Relative Bioavailability and Safety Trial With Two Differing Strength Tablets (3 x 5 mg vs. 1 x 15 mg) of Sublingually Administered Org 5222 in Subjects With Schizophrenia or Schizoaffective Disorder.

Organon and Co·interventional·Posted Apr 12, 2010·Updated Feb 9, 2022

In Brief

A Phase 2 clinical trial evaluating Asenapine 3x5mg followed by 1x15mg and Asenapine 1x15mg followed by 3x5mg for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 8 participants.

Detailed Summary

A trial to compare if one 15 mg under the tongue tablet is equal to three 5 mg under the tongue tablets of Org 5222 (asenapine) in subjects with schizophrenia or schizoaffective disorder delivered.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 12, 2010
Enrollment StartOct 1, 2002
Primary CompletionDec 1, 2002
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.2 years ago

Interventions

Asenapine 3x5mg followed by 1x15mgdrug

Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days

Asenapine 1x15mg followed by 3x5mgdrug

One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.