A phase III randomised, double-blind, active comparator-controlled clinical trial to study the safety and efficacy of lurasidone in subjects with schizophrenia (PEARL 3 extension study)
| ISRCTN | ISRCTN44297014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44297014 |
| Secondary identifying numbers | D1050234 |
- Submission date
- 14/11/2008
- Registration date
- 26/05/2009
- Last edited
- 26/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kaushik Sarma
Scientific
Scientific
Dainippon Sumitomo Pharma America Inc.
One Bridge Plaza
Suite 510
Fort Lee
New Jersey
07024
United States of America
Study information
| Study design | Randomised double-blind active comparator-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | PEARL 3 Extension Study |
| Study objectives | Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long-term among schizophrenic outpatients with chronic schizophrenia. |
| Ethics approval(s) | USA: Copernicus Group IRB, approved on 05/09/2008. All other centres will seek ethics approval before recruitment of the first participant. |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | Subjects who meet entry criteria will continue treatment with either flexibly dosed lurasidone or quetiapine XR based on their treatment assignment in Study D1050233 in a double-blinded fashion. Subjects treated with placebo in Study D1050233 will be treated with lurasidone. Arm 1: Lurasidone HCI 40-160 mg/day orally for 12 months Arm 2: Quetiapine XR 200-800 mg/day orally for 12 months |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Lurasidone HCl, quetiapine XR |
| Primary outcome measure | 1. Primary efficacy endpoint: 1.1. Time to relapse of psychotic symptoms in subjects to measure the long-term maintenance of antipsychotic efficacy of lurasidone compared with quetiapine XR. 2. Primary safety endpoints: The proportion of subjects with: 2.1. Adverse Events (AEs) 2.2. Discontinuations due to AEs 2.3. Serious Adverse Events (SAEs) AEs will be monitored throughout the study until Month 12. |
| Secondary outcome measures | Efficacy endpoints of interest: Time to relapse of psychotic symptoms. Mean change from D1050233 baseline in the Positive and Negative Syndrome Scale (PANSS): positive score, negative score, and excitability score. PANSS will be carried out at Month 3, 6, 9, 12 in this extension study. |
| Overall study start date | 01/12/2008 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Approximately 240 |
| Key inclusion criteria | Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent. Principal inclusion criteria: 1. Males and females 18-75 years of age inclusive 2. Provide written informed consent 3. Completed all required assessments on the final study visit in Study D1050233 4. Suitable for treatment in an outpatient setting |
| Key exclusion criteria | 1. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia) 2. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Colombia
- Germany
- India
- Philippines
- Romania
- Russian Federation
- Ukraine
- United States of America
Study participating centre
Dainippon Sumitomo Pharma America Inc.
New Jersey
07024
United States of America
07024
United States of America
Sponsor information
Dainippon Sumitomo Pharma America Inc. (USA)
Industry
Industry
One Bridge Plaza
Suite 510
Fort Lee
New Jersey
07024
United States of America
| Website | http://www.ds-pharma.co.jp/english |
|---|---|
"ROR" |
https://ror.org/04vwbmb32 |
Funders
Funder type
Industry
Dainippon Sumitomo Pharma Co. Ltd. (Japan)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Dainippon Sumitomo Pharma Co., Ltd.
- Location
- Japan
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
