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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00143026 |
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Date of registration:
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31/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States
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Scientific title:
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Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. |
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Date of first enrolment:
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July 2005 |
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Target sample size:
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184 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00143026 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Philippines
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Taiwan
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Thailand
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3
symptoms
- Motor functions must be regarded as non-disabling by the patient
Exclusion Criteria:
- History, signs or symptoms suggesting the diagnosis of atypical or secondary
parkinsonism
- History of dyskinesia
- Previous or current use of entacapone or tolcapone
- Unstable Parkinson's disease patients requiring/receiving regimens of levodopa
- Subjects taking levodopa/DDCI controlled release or extended release formulations
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: carbidopa, levodopa, entacapone
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Primary Outcome(s)
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Quality of life assessment
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Secondary Outcome(s)
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Symptom control change from baseline
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Change from baseline in proportion of patients experiencing wearing-off
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Change from baseline in number of wearing-off symptoms
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Secondary ID(s)
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CELC200A2406
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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