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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 31, 2008 | ||||
| Last Updated Date | October 29, 2009 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety i. Incidence & severity of AEs, ii. Drop outs, iii. Days from treatment start to hallucination onset Efficacy i. Changes in UPDRS Part I (Item 3) & III scores, ii. Change in BDI total score at Week 12 [ Time Frame: 12 Weeks ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety i. Incidence & severity of AE ii. Drop outs iii. Days from treatment start to hallucination onset Efficacy i. Change in the UPDRS Part I (Item 3) & Part III score from baseline ii. Change in BDI total score at Week 12 from baselin [ Time Frame: 12 Weeks ] | ||||
| Change History | Complete list of historical versions of study NCT00614575 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Efficacy i. Percentage of patients with 50% decrease in the BDI score from baseline [ Time Frame: 12 Weeks ] | ||||
| Original Secondary Outcome Measures ICMJE |
Efficacy i. Percentage of patients with 50% decrease in the BDI score from baseline [ Time Frame: 12 Weeks ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Survey on PD Patients With Depressive Symptoms | ||||
| Official Title ICMJE | BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms) | ||||
| Brief Summary | The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy. i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Parkinson Disease | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1087 | ||||
| Completion Date | |||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance. Exclusion Criteria: PD patients with the past history of suicidal attempt, suicidal ideation or tendency |
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00614575 | ||||
| Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
| Study ID Numbers ICMJE | 248.635 | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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