Safety and efficacy trial of two doses of lurasidone in acutely psychotic subjects with schizophrenia (PEARL 3)
| ISRCTN | ISRCTN64695913 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64695913 |
| ClinicalTrials.gov number | NCT00790192 |
| Secondary identifying numbers | D1050233 |
- Submission date
- 14/11/2008
- Registration date
- 26/05/2009
- Last edited
- 10/04/2019
- 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
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 placebo- and 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 | A phase III randomised, double-blind, placebo- and active comparator-controlled clinical trial to study the safety and efficacy of two doses of lurasidone in acutely psychotic subjects with schizophrenia (PEARL 3) |
| Study acronym | PEARL 3 |
| Study objectives | Lurasidone HCl is a compound being developed for the treatment of schizophrenia. The clinical study is designed to test the hypothesis that lurasidone is effective, tolerable and safe as compared with quetiapine XR short-term among acutely psychotic patients 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 | There is a 14-day screening period and a 3 to 7-day placebo washout period before randomisation of the participants for the trial. Patients will be randomly assigned to one of the four treatment arms in equal numbers: Arm 1: Lurasidone HCI 80 mg/day orally for 6 weeks Arm 2: Lurasidone HCl 160 mg/day orally for 6 weeks Arm 3: Quetiapine XR 600 mg/day for 6 weeks Arm 4: Placebo for 6 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Lurasidone, quetiapine |
| Primary outcome measure | Primary Efficacy Endpoint: Mean change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (Week 6). Primary Safety Endpoints: The proportion of subjects with the following at Week 6: 1. Adverse Events (AEs) 2. Discontinuations due to AEs 3. Serious Adverse Events (SAEs) |
| Secondary outcome measures | Key secondary efficacy endpoints: Mean change from baseline in: 1. Clinical Global Impressions Severity (CGI-S) score, assessed at baseline, Day 4, then every week until Week 6 2. PANSS total score, assessed at baseline, Day 4, then every week until Week 6 |
| Overall study start date | 15/10/2008 |
| Completion date | 12/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 480 |
| Key inclusion criteria | 1. Provide written informed consent and aged between 18 and 75 years of age (both males and females are eligible) 2. Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia 3. Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study 4. Able and agrees to remain off prior antipsychotic medication for the duration of study 5. Good physical health on the basis of medical history, physical examination, and laboratory screening 6. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits |
| Key exclusion criteria | 1. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property 2. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia) 3. Used investigational compound within 30 days 4. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months |
| Date of first enrolment | 15/10/2008 |
| Date of final enrolment | 12/12/2009 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/11/2013 | 10/04/2019 | Yes | No |
| Results article | results | 01/08/2015 | 10/04/2019 | Yes | No |
Editorial Notes
10/04/2019: Publication reference added.
22/03/2016: added link to results - basic reporting.
