NCT02287584

Confirmatory Study of DSP-5423P in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: Sumitomo Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	DSP-5423P Placebo	DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
DRUG	DSP-5423P 40mg	DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
DRUG	DSP-5423P 80mg	DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
DRUG	DSP-5423P Placebo-to-Flex	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
DRUG	DSP-5423P Active-to-Flex	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

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-11-10
• Last updated: 2022-04-12
• Results posted: 2020-12-23

Locations

8 sites across 8 countries: China, Japan, Malaysia, Philippines, Russia, South Korea, Taiwan, Ukraine