CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 580 enrolled
Drug / intervention
DSP-5423P Placebo +4 moredrug
Likely dose
DSP-5423P 40mgfrom 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/NCT02287584
NCT02287584Phase 3Completed
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Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Sumitomo Pharma Co., Ltd.·interventional·Posted Nov 10, 2014·Updated Apr 12, 2022

In Brief

A Phase 3 clinical trial evaluating DSP-5423P Placebo, DSP-5423P 40mg, and 3 other interventions for Schizophrenia. Completed, enrolled 580 participants across 8 sites in 8 countries.

Detailed Summary

The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesChina, Japan, Malaysia, Philippines, Russia, South Korea, Taiwan, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 10, 2014
Enrollment StartDec 1, 2014
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 11.6 years ago

Interventions

DSP-5423P Placebodrug

DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily

DSP-5423P 40mgdrug

DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P 80mgdrug

DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P Placebo-to-Flexdrug

DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily DSP-5423P Flex: DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P Active-to-Flexdrug

DSP-5423P Active: DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily DSP-5423P Flex: DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily