Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit
This study has been completed.
Sponsor:
University Hospital, Akershus
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Christofer Lundqvist, Akershus University College
ClinicalTrials.gov Identifier:
NCT00272688
First received: January 6, 2006
Last updated: October 31, 2011
Last verified: October 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 6, 2006 | ||||||||
| Last Updated Date | October 31, 2011 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00272688 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England) [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit | ||||||||
| Official Title ICMJE | Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation | ||||||||
| Brief Summary | An open, observational health economic study to estimate marginal cost and health consequences of replacing conventional Parkinsons disease therapy with intraduodenal levodopa administered continuously |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Parkinson Disease | ||||||||
| Intervention ICMJE | Drug: Levodopa (drug), intraduodenal administration | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 10 | ||||||||
| Completion Date | May 2009 | ||||||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00272688 | ||||||||
| Other Study ID Numbers ICMJE | Duo-HRQoL-2 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Christofer Lundqvist, Akershus University College | ||||||||
| Study Sponsor ICMJE | University Hospital, Akershus | ||||||||
| Collaborators ICMJE | Solvay Pharmaceuticals | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Akershus | ||||||||
| Verification Date | October 2011 | ||||||||
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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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