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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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19 February 2015 |
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Main ID: |
NCT02112812 |
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Date of registration:
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10/04/2014 |
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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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Effects of Helicobacter Pylori Infection Eradication in Patients With Parkinson's Disease
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Scientific title:
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A Study on Clinical Response Following Eradication Therapy of Helicobacter Pylori Infection in Parkinson's Disease |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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82 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02112812 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Norlinah Mohamed Ibrahim, MBBCH, MRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Medicine, Faculty of Medicine, National University of Malaysia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease (PD) by a neurologist
- Age more than 18 years
- Written informed consent given either by the patient or next of kin
- Patient on L-DOPA therapy
Exclusion Criteria:
- Patients with a diagnosis of secondary parkinsonism, and Parkinson's plus syndrome
- History of recent proton pump inhibitors (PPIs) or Histamine (H2) antagonist use for
at least 4 weeks prior to the urea breath test
- History of recent antibiotics use (less than 6 months)
- Inability to perform urea breath test
Age minimum:
17 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Response to Levodopa
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Motor Outcomes
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Quality of Life Outcomes
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Intervention(s)
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Drug: Eradication of Helcobacter Pylori
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Drug: Eradication therapy for H.pylori infection
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Drug: Eradication therapy for Helicobacter pylori
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Primary Outcome(s)
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Improvement in L-dopa 'onset' time and L-dopa 'on-time' duration following H.pylori eradication
[Time Frame: 3 months post eradication]
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1. H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time' duration.
[Time Frame: 3months]
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Secondary Outcome(s)
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Improvement in motor disability after eradication therapy of H. pylori, assessed using UPDRS-III , and improvement in quality of life using PDQ39
[Time Frame: 3 months post eradication]
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Secondary ID(s)
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FF0452012
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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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