A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00139867
First received: August 29, 2005
Last updated: September 9, 2009
Last verified: September 2009
| Tracking Information | |||||
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| First Received Date ICMJE | August 29, 2005 | ||||
| Last Updated Date | September 9, 2009 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | May 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00139867 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| 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 | A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease | ||||
| Official Title ICMJE | A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease | ||||
| Brief Summary | The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease. |
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| Detailed Description | See approved Package Insert for Adverse Event information. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
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| Condition ICMJE | Parkinson's Disease | ||||
| Intervention ICMJE | Drug: PARCOPA | ||||
| 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 | Not Provided | ||||
| Completion Date | May 2004 | ||||
| Primary Completion Date | May 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00139867 | ||||
| Other Study ID Numbers ICMJE | SP780 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | UCB, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | UCB, Inc. | ||||
| Verification Date | September 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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