An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

323

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Schizophrenia
Interventions
DRUG

Paliperidone palmitate

Paliperidone palmitate will be given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.

DRUG

Placebo

Matching Placebo will be given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.

Trial Locations (56)

Unknown

Fujioka

Fujisawa

Fukui

Fukuoka

Hadano

Ichikawa

Itoman

Kanzaki

Kashihara

Kasuya

Kawasaki

Kitagunma

Kitakyushu

Kobe

Kodaira

Koshigaya

Kumagaya

Kumamoto

Kurayoshi

Kure

Kurume

Mitaka

Miyazaki

Moriguchi

Nanyō

Nishinomiya

Ohta

Okinawa

Oyabe

Sakai

Shibukawa

Takatsuki

Tamana

Tokyo

Toyama

Toyoake

Urasoe

Yatsushiro

Yokkaichi

Yokohama

Busan

Chungcheongbuk-Do

Daegu

Deajun

Incheon

Inchun

Jeonju

Seongnam

Seoul

Bali Township, Taipei County

Changhua

Hualien City

Kaohsiung City

Tainan City

Taipei

Taoyuan District

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY