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Confirmatory Study of DSP-5423P in Patients With Schizophrenia

NCT02287584 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2022-04-12

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Director, Drug Development Division · Sumitomo Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China
  • Japan
  • Malaysia
  • Philippines
  • Russia
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287584 on ClinicalTrials.gov