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Trial record 91 of 405 for:    ARIPIPRAZOLE

A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

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: NCT01617460
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autistic Disorder
Intervention Drug: Aripiprazole
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole
Hide Arm/Group Description

Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.

The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.

Period Title: Overall Study
Started 86
Completed 46
Not Completed 40
Reason Not Completed
Adverse Event             10
Physician Decision             16
Protocol Violation             5
Withdrawal by Subject             9
Arm/Group Title Aripiprazole
Hide Arm/Group Description

Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.

The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.

Overall Number of Baseline Participants 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
<=18 years
86
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants
10.0  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
Female
17
  19.8%
Male
69
  80.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 86 participants
86
1.Primary Outcome
Title Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
Hide Description The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.
Time Frame Baseline, the final administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole
Hide Arm/Group Description:

Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.

The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.

Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.2  (8.1)
Time Frame From the start date of investigational medicinal product (IMP) administration to date of the final examination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole
Hide Arm/Group Description

Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.

The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.

All-Cause Mortality
Aripiprazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole
Affected / at Risk (%)
Total   10/86 (11.63%) 
General disorders   
Malaise  1  1/86 (1.16%) 
Infections and infestations   
Lymphadenitis bacterial  2  1/86 (1.16%) 
Injury, poisoning and procedural complications   
Hand fracture  2  1/86 (1.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Melanocytic naevus  2  1/86 (1.16%) 
Nervous system disorders   
Autism  2  2/86 (2.33%) 
Psychiatric disorders   
Agitation  2  1/86 (1.16%) 
Renal and urinary disorders   
Glomerulonephritis acute  2  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders   
Adenoidal hypertrophy  2  2/86 (2.33%) 
Status asthmaticus  2  1/86 (1.16%) 
Tonsillar hypertrophy  2  1/86 (1.16%) 
Social circumstances   
Sexual abuse  2  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA/J 19.0
2
Term from vocabulary, MedDRA/J Ver 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole
Affected / at Risk (%)
Total   84/86 (97.67%) 
Eye disorders   
Conjunctivitis allergic  1  5/86 (5.81%) 
Gastrointestinal disorders   
Dental caries  2  8/86 (9.30%) 
Diarrhoea  2  5/86 (5.81%) 
Nausea  2  6/86 (6.98%) 
Salivary hypersecretion  2  6/86 (6.98%) 
Vomiting  2  12/86 (13.95%) 
General disorders   
Pyrexia  2  8/86 (9.30%) 
Infections and infestations   
Bronchitis  2  5/86 (5.81%) 
Gastroenteritis  2  10/86 (11.63%) 
Influenza  2  25/86 (29.07%) 
Nasopharyngitis  2  53/86 (61.63%) 
Pharyngitis  2  5/86 (5.81%) 
Rhinitis  2  5/86 (5.81%) 
Upper respiratory tract infection  2  8/86 (9.30%) 
Injury, poisoning and procedural complications   
Arthropod bite  2  5/86 (5.81%) 
Contusion  2  6/86 (6.98%) 
Investigations   
Weight increased  2  21/86 (24.42%) 
Metabolism and nutrition disorders   
Increased appetite  2  10/86 (11.63%) 
Decreased appetite  2  7/86 (8.14%) 
Nervous system disorders   
Autism  2  5/86 (5.81%) 
Headache  2  5/86 (5.81%) 
Somnolence  2  28/86 (32.56%) 
Respiratory, thoracic and mediastinal disorders   
Rhinitis allergic  2  9/86 (10.47%) 
Upper respiratory tract inflammation  2  9/86 (10.47%) 
Skin and subcutaneous tissue disorders   
Eczema  2  6/86 (6.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA/J 19.0
2
Term from vocabulary, MedDRA/J Ver 19.0
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
Name/Title: Director of Clinical Trials
Organization: Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01617460     History of Changes
Other Study ID Numbers: 031-11-003
First Submitted: June 8, 2012
First Posted: June 12, 2012
Results First Submitted: May 29, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017