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Safety and Tolerability Study of Drug to Treat Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00044005
Recruitment Status : Completed
First Posted : August 20, 2002
Results First Posted : May 19, 2011
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Lurasidone 20 mg
Drug: Lurasidone 40 mg
Drug: Lurasidone 80mg
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lurasidone 20 mg Lurasidone 40 mg Lurasidone 80mg
Hide Arm/Group Description Lurasdione 20 mg oral tablets Lurasidone 40 mg oral tablets Lurasidone 80mg oral tablets
Period Title: Overall Study
Started 32 33 33
Completed 13 19 11
Not Completed 19 14 22
Arm/Group Title Lurasidone 20 mg Lurasidone 40 mg Lurasidone 80mg Total
Hide Arm/Group Description Lurasdione 20 mg oral tablets Lurasidone 40 mg oral tablets Lurasidone 80mg oral tablets Total of all reporting groups
Overall Number of Baseline Participants 32 33 33 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 33 participants 33 participants 98 participants
40.8  (7.8) 42.2  (12.4) 40.8  (10.7) 41.3  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 33 participants 98 participants
Female
11
  34.4%
12
  36.4%
5
  15.2%
28
  28.6%
Male
21
  65.6%
21
  63.6%
28
  84.8%
70
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 33 participants 33 participants 98 participants
32 33 33 98
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lurasidone 20 mg Lurasidone 40 mg Lurasidone 80mg
Hide Arm/Group Description:
Lurasdione 20 mg oral tablets
Lurasidone 40 mg oral tablets
Lurasidone 80mg oral tablets
Overall Number of Participants Analyzed 32 33 33
Measure Type: Number
Unit of Measure: participants
19 22 18
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lurasidone 20 mg Lurasidone 40 mg Lurasidone 80mg
Hide Arm/Group Description Lurasdione 20 mg oral tablets Lurasidone 40 mg oral tablets Lurasidone 80mg oral tablets
All-Cause Mortality
Lurasidone 20 mg Lurasidone 40 mg Lurasidone 80mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lurasidone 20 mg Lurasidone 40 mg Lurasidone 80mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/32 (9.38%)      6/33 (18.18%)      3/33 (9.09%)    
Cardiac disorders       
Sinus tachycardia  3/32 (9.38%)  3 6/6 (100.00%)  6 3/3 (100.00%)  3
Injury, poisoning and procedural complications       
Fall  0/32 (0.00%)  0 1/33 (3.03%)  1 0/33 (0.00%)  0
Lower Limb Fracture  0/32 (0.00%)  0 1/33 (3.03%)  1 0/33 (0.00%)  0
Pelvic Fracture  0/32 (0.00%)  0 1/33 (3.03%)  1 0/33 (0.00%)  0
Metabolism and nutrition disorders       
Hypokalaemia  0/32 (0.00%)  0 1/33 (3.03%)  1 0/33 (0.00%)  0
Psychiatric disorders       
Schizophrenia  2/32 (6.25%)  2 4/33 (12.12%)  4 1/33 (3.03%)  1
Suicidal Behavior  0/32 (0.00%)  0 1/33 (3.03%)  1 1/33 (3.03%)  1
Suicidal Ideation  1/32 (3.13%)  1 0/33 (0.00%)  0 1/33 (3.03%)  1
Surgical and medical procedures       
Endotracheal Intubation  0/32 (0.00%)  0 1/33 (3.03%)  1 0/33 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lurasidone 20 mg Lurasidone 40 mg Lurasidone 80mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/32 (59.38%)      22/33 (66.67%)      18/33 (54.55%)    
Ear and labyrinth disorders       
Ear Pain  0/32 (0.00%)  0 2/33 (6.06%)  2 0/33 (0.00%)  0
Eye disorders       
Eye Pain  0/32 (0.00%)  0 2/33 (6.06%)  2 0/33 (0.00%)  0
Gastrointestinal disorders       
Constipation  0/32 (0.00%)  0 2/33 (6.06%)  2 1/33 (3.03%)  1
Diarrhoea  2/32 (6.25%)  2 1/33 (3.03%)  1 0/33 (0.00%)  0
Dry Mouth  0/32 (0.00%)  0 0/33 (0.00%)  0 2/33 (6.06%)  2
Dyspepsia  2/32 (6.25%)  2 0/33 (0.00%)  0 1/33 (3.03%)  1
Nausea  1/32 (3.13%)  1 3/33 (9.09%)  3 2/33 (6.06%)  2
Salivary Hypersecretion  1/32 (3.13%)  1 2/33 (6.06%)  2 0/33 (0.00%)  0
Toothache  1/32 (3.13%)  1 3/33 (9.09%)  3 2/33 (6.06%)  2
Vomiting  3/32 (9.38%)  3 2/33 (6.06%)  2 3/33 (9.09%)  3
General disorders       
Fatigue  1/32 (3.13%)  1 0/33 (0.00%)  0 2/33 (6.06%)  2
Oedema Peripheral  0/32 (0.00%)  0 2/33 (6.06%)  2 0/33 (0.00%)  0
Immune system disorders       
Seasonal Allergy  0/32 (0.00%)  0 0/33 (0.00%)  0 2/33 (6.06%)  2
Infections and infestations       
Influenza  1/32 (3.13%)  1 2/33 (6.06%)  2 0/33 (0.00%)  0
Nasopharyngitis  3/32 (9.38%)  3 4/33 (12.12%)  4 0/33 (0.00%)  0
Upper Respiratory Tract Infection  3/32 (9.38%)  3 1/33 (3.03%)  1 1/33 (3.03%)  1
Urinary Tract Infection  1/32 (3.13%)  1 3/33 (9.09%)  3 0/33 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  2/32 (6.25%)  2 0/33 (0.00%)  0 0/33 (0.00%)  0
Skin Laceration  2/32 (6.25%)  2 0/33 (0.00%)  0 0/33 (0.00%)  0
Investigations       
Blood Creatine Phosphokinase Increased  2/32 (6.25%)  2 1/33 (3.03%)  1 1/33 (3.03%)  1
Blood Pressure Increased  0/32 (0.00%)  0 2/33 (6.06%)  2 0/33 (0.00%)  0
Weight Decreased  1/32 (3.13%)  1 1/33 (3.03%)  1 2/33 (6.06%)  2
Weight Increased  1/32 (3.13%)  1 0/33 (0.00%)  0 2/33 (6.06%)  2
Musculoskeletal and connective tissue disorders       
Musculoskeletal Pain  0/32 (0.00%)  0 2/33 (6.06%)  2 0/33 (0.00%)  0
Musculoskeletal Stiffness  1/32 (3.13%)  1 0/33 (0.00%)  0 2/33 (6.06%)  2
Pain in Extremity  0/32 (0.00%)  0 2/33 (6.06%)  2 0/33 (0.00%)  0
Nervous system disorders       
Akathisia  2/32 (6.25%)  2 2/33 (6.06%)  2 2/33 (6.06%)  2
Dizziness  2/32 (6.25%)  2 6/33 (18.18%)  6 1/33 (3.03%)  1
Dyskinesia  0/32 (0.00%)  0 1/33 (3.03%)  1 2/33 (6.06%)  2
Headache  5/32 (15.63%)  5 5/33 (15.15%)  5 5/33 (15.15%)  5
Sedation  0/32 (0.00%)  0 4/33 (12.12%)  4 1/33 (3.03%)  1
Somnolence  2/32 (6.25%)  2 1/33 (3.03%)  1 1/33 (3.03%)  1
Psychiatric disorders       
Agitation  1/32 (3.13%)  1 2/33 (6.06%)  2 1/33 (3.03%)  1
Anxiety  0/32 (0.00%)  0 3/33 (9.09%)  3 1/33 (3.03%)  1
Depressed Mood  2/32 (6.25%)  2 0/33 (0.00%)  0 1/33 (3.03%)  1
Insomnia  3/32 (9.38%)  3 1/33 (3.03%)  1 2/33 (6.06%)  2
Suicidal Ideation  2/32 (6.25%)  2 0/33 (0.00%)  0 0/33 (0.00%)  0
Depression  1/32 (3.13%)  1 0/33 (0.00%)  0 4/33 (12.12%)  4
Respiratory, thoracic and mediastinal disorders       
Cough  2/32 (6.25%)  2 2/33 (6.06%)  2 0/33 (0.00%)  0
Oropharyngeal Pain  0/32 (0.00%)  0 1/33 (3.03%)  1 3/33 (9.09%)  3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Josephine Cucchiaro, PhD
Organization: Sunovion
Phone: 201-592-2050
EMail: josepine.cucchiaro@sunovion.com
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00044005     History of Changes
Other Study ID Numbers: D1050174
First Submitted: August 16, 2002
First Posted: August 20, 2002
Results First Submitted: February 16, 2011
Results First Posted: May 19, 2011
Last Update Posted: April 17, 2014