Safety and Tolerability Study of Drug to Treat Schizophrenia | NCT00044005

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lurasidone 20 mg	Experimental	Lurasidone 20 mg oral tablet	Drug: Lurasidone 20 mg
Lurasidione 40 mg	Experimental	Lurasidone 40 mg oral tablet	Drug: Lurasidone 40 mg
Lurasidone 80mg	Experimental	Lurasidone 80mg oral tablet	Drug: Lurasidone 80mg

Name	Type	Description	Arm Group Labels	Other Names
Lurasidone 20 mg	Drug	Lurasidone 20mg oral tablet taken once daily for 6-months	Lurasidone 20 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events	The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.	6-months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director, MD	Sumitomo Pharma America, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Psychiatry Pharmaceutical		Birmingham	Alabama	35209	United States
Institute for Psychopharmacology Research

Results Section

Participant Flow Module

ID	Title	Description
FG000	Lurasidone 20 mg	Lurasdione 20 mg oral tablets
FG001	Lurasidone 40 mg	Lurasidone 40 mg oral tablets

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Lurasidone 20 mg	Lurasdione 20 mg oral tablets
BG001	Lurasidone 40 mg	Lurasidone 40 mg oral tablets
BG002	Lurasidone 80mg	Lurasidone 80mg oral tablets
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00040.8± 7.8 BG00142.2± 12.4 BG00240.8± 10.7 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00011 BG00112 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00032 BG00133 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events

The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.

No formal hypothesis testing was performed. However,descriptive statistics were provided and data summarized. Safety analyses were conducted on the safety population, that included all subjects who had received at least 1 dose of open-label study medication.

Posted

Feb 2011

Number

participants

6-months

ID	Title	Description
OG000	Lurasidone 20 mg	Lurasdione 20 mg oral tablets
OG001	Lurasidone 40 mg	Lurasidone 40 mg oral tablets
OG002	Lurasidone 80mg	Lurasidone 80mg oral tablets

Units	Counts
Participants	OG00032 OG00133 OG00233

Title

Denominators

Categories

Title	Measurements
	OG00019± 7.8 OG00122± 12.4 OG00218± 10.7

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lurasidone 20 mg	Lurasdione 20 mg oral tablets	3	32	19	32
EG001	Lurasidone 40 mg	Lurasidone 40 mg oral tablets	6	33	22	33
EG002	Lurasidone 80mg	Lurasidone 80mg oral tablets	3	33	18	33

Serious Adverse Events

Term	Organ System	Statistical Information
Sinus tachycardia	Cardiac disorders	EG0003 events3 affected32 at risk EG0016 events6 affected6 at risk EG0023 events3 affected3 at risk
Fall	Injury, poisoning and procedural complications	EG0000 events0 affected32 at risk EG0011 events1 affected33 at risk EG0020 events0 affected33 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	EG0000 events0 affected32 at risk EG0011 events1 affected33 at risk EG0020 events0 affected33 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	EG0000 events0 affected32 at risk EG0011 events1 affected33 at risk EG0020 events0 affected33 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0000 events0 affected32 at risk EG0011 events1 affected33 at risk EG0020 events0 affected33 at risk
Schizophrenia	Psychiatric disorders	EG0002 events2 affected32 at risk EG0014 events4 affected33 at risk EG0021 events1 affected33 at risk
Suicidal Behavior	Psychiatric disorders	EG0000 events0 affected32 at risk EG0011 events1 affected33 at risk EG0021 events1 affected33 at risk
Suicidal Ideation	Psychiatric disorders	EG0001 events1 affected32 at risk EG0010 events0 affected33 at risk EG0021 events1 affected33 at risk
Endotracheal Intubation	Surgical and medical procedures	EG0000 events0 affected32 at risk EG0011 events1 affected33 at risk EG0020 events0 affected33 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Ear Pain	Ear and labyrinth disorders	EG0000 events0 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Eye Pain	Eye disorders	EG0000 events0 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Constipation	Gastrointestinal disorders	EG0000 events0 affected32 at risk EG0012 events2 affected33 at risk EG0021 events1 affected33 at risk
Diarrhoea	Gastrointestinal disorders	EG0002 events2 affected32 at risk EG0011 events1 affected33 at risk EG0020 events0 affected33 at risk
Dry Mouth	Gastrointestinal disorders	EG0000 events0 affected32 at risk EG0010 events0 affected33 at risk EG0022 events2 affected33 at risk
Dyspepsia	Gastrointestinal disorders	EG0002 events2 affected32 at risk EG0010 events0 affected33 at risk EG0021 events1 affected33 at risk
Nausea	Gastrointestinal disorders	EG0001 events1 affected32 at risk EG0013 events3 affected33 at risk EG0022 events2 affected33 at risk
Salivary Hypersecretion	Gastrointestinal disorders	EG0001 events1 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Toothache	Gastrointestinal disorders	EG0001 events1 affected32 at risk EG0013 events3 affected33 at risk EG0022 events2 affected33 at risk
Vomiting	Gastrointestinal disorders	EG0003 events3 affected32 at risk EG0012 events2 affected33 at risk EG0023 events3 affected33 at risk
Fatigue	General disorders	EG0001 events1 affected32 at risk EG0010 events0 affected33 at risk EG0022 events2 affected33 at risk
Oedema Peripheral	General disorders	EG0000 events0 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Seasonal Allergy	Immune system disorders	EG0000 events0 affected32 at risk EG0010 events0 affected33 at risk EG0022 events2 affected33 at risk
Influenza	Infections and infestations	EG0001 events1 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Nasopharyngitis	Infections and infestations	EG0003 events3 affected32 at risk EG0014 events4 affected33 at risk EG0020 events0 affected33 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG0003 events3 affected32 at risk EG0011 events1 affected33 at risk EG0021 events1 affected33 at risk
Urinary Tract Infection	Infections and infestations	EG0001 events1 affected32 at risk EG0013 events3 affected33 at risk EG0020 events0 affected33 at risk
Fall	Injury, poisoning and procedural complications	EG0002 events2 affected32 at risk EG0010 events0 affected33 at risk EG0020 events0 affected33 at risk
Skin Laceration	Injury, poisoning and procedural complications	EG0002 events2 affected32 at risk EG0010 events0 affected33 at risk EG0020 events0 affected33 at risk
Blood Creatine Phosphokinase Increased	Investigations	EG0002 events2 affected32 at risk EG0011 events1 affected33 at risk EG0021 events1 affected33 at risk
Blood Pressure Increased	Investigations	EG0000 events0 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Weight Decreased	Investigations	EG0001 events1 affected32 at risk EG0011 events1 affected33 at risk EG0022 events2 affected33 at risk
Weight Increased	Investigations	EG0001 events1 affected32 at risk EG0010 events0 affected33 at risk EG0022 events2 affected33 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG0000 events0 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	EG0001 events1 affected32 at risk EG0010 events0 affected33 at risk EG0022 events2 affected33 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG0000 events0 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Akathisia	Nervous system disorders	EG0002 events2 affected32 at risk EG0012 events2 affected33 at risk EG0022 events2 affected33 at risk
Dizziness	Nervous system disorders	EG0002 events2 affected32 at risk EG0016 events6 affected33 at risk EG0021 events1 affected33 at risk
Dyskinesia	Nervous system disorders	EG0000 events0 affected32 at risk EG0011 events1 affected33 at risk EG0022 events2 affected33 at risk
Headache	Nervous system disorders	EG0005 events5 affected32 at risk EG0015 events5 affected33 at risk EG0025 events5 affected33 at risk
Sedation	Nervous system disorders	EG0000 events0 affected32 at risk EG0014 events4 affected33 at risk EG0021 events1 affected33 at risk
Somnolence	Nervous system disorders	EG0002 events2 affected32 at risk EG0011 events1 affected33 at risk EG0021 events1 affected33 at risk
Agitation	Psychiatric disorders	EG0001 events1 affected32 at risk EG0012 events2 affected33 at risk EG0021 events1 affected33 at risk
Anxiety	Psychiatric disorders	EG0000 events0 affected32 at risk EG0013 events3 affected33 at risk EG0021 events1 affected33 at risk
Depressed Mood	Psychiatric disorders	EG0002 events2 affected32 at risk EG0010 events0 affected33 at risk EG0021 events1 affected33 at risk
Insomnia	Psychiatric disorders	EG0003 events3 affected32 at risk EG0011 events1 affected33 at risk EG0022 events2 affected33 at risk
Suicidal Ideation	Psychiatric disorders	EG0002 events2 affected32 at risk EG0010 events0 affected33 at risk EG0020 events0 affected33 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected32 at risk EG0012 events2 affected33 at risk EG0020 events0 affected33 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected32 at risk EG0011 events1 affected33 at risk EG0023 events3 affected33 at risk
Depression	Psychiatric disorders	EG0001 events1 affected32 at risk EG0010 events0 affected33 at risk EG0024 events4 affected33 at risk

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders