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This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole (Abilify® Tablets/Abilify® ODT) |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency (n) of Subjects With Adverse Event | Frequency (n) and Percentage(%) of subjects with Adverse event | Follow-up at least once from baseline to 6 weeks and at least 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment *TS-CGI scale 0=Not assessed
| at least 6, 12 weeks interval from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients 6 to 18 years of age with Tourette's Disorder according to the approved product market authorization
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | South Korea | ||||
| Chonbuk National University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole (Abilify® Tablets/Abilify® ODT) |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole (Abilify® Tablets/Abilify® ODT) | Pediatric patients with Tourette syndrome aged 6-18 years who were administered with Aripiprazole (Abilify® Tablets/Abilify® ODT) according to the approved dosage. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Frequency (n) of Subjects With Adverse Event | Frequency (n) and Percentage(%) of subjects with Adverse event | Posted | Count of Participants | Participants | Follow-up at least once from baseline to 6 weeks and at least 12weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole (Abilify® Tablets/Abilify® ODT) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neuritis | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeong, Hyo-Won | KoreaOtsukaPharma | jhw0159@otsuka.co.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2014 | Dec 18, 2017 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Jeonju |
| 561-712 |
| South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Seoul Medical Center | Seoul | 131-795 | South Korea |
| Participants |
|
| Sex: Female, Male | Sex information of 1patient haven't been examined although we asked inversigater to resolve the query.So, it is missing value. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) | Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment *TS-CGI scale 0=Not assessed
| Posted | Mean | Standard Deviation | score on a scale | at least 6, 12 weeks interval from baseline |
|
|
|
| 1 |
| 648 |
| 49 |
| 648 |
| Appetite increased | Psychiatric disorders |
|
| Anorexia | Psychiatric disorders |
|
| Apathy | Psychiatric disorders |
|
| Nervousness | Psychiatric disorders |
|
| Emotional liability | Psychiatric disorders |
|
| Anxiety | Psychiatric disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Mouth dry | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Enteritis | Gastrointestinal disorders |
|
| Extrapyramidal disorder | Nervous system disorders |
|
| Hyperkinesia | Nervous system disorders |
|
| Hypertonia | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Dizziness | Nervous system disorders |
|
| Tremor | Nervous system disorders |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders |
|
| Weight increase | Metabolism and nutrition disorders |
|
| Fatigue | General disorders |
|
| Eczema | Skin and subcutaneous tissue disorders |
|
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| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| Mean change in the TS-CGI |
|