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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000016893 |
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Date of registration:
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01/04/2015 |
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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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A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression.
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Scientific title:
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A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine. |
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Date of first enrolment:
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2014/09/22 |
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Target sample size:
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50 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019588 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hirotaka Iwaki |
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Address:
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Shitsukawa, Toon, Ehime
Japan |
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Telephone:
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089-960-5095 |
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Email:
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h-iwaki@m.ehime-u.ac.jp |
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Affiliation:
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Ehime University Hospital Dept. of Clinical pharmacology and Neurology |
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Name:
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Hirotaka Iwaki |
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Address:
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Shitsukawa, Toon, Ehime
Japan |
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Telephone:
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089-960-5095 |
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Email:
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h-iwaki@m.ehime-u.ac.jp |
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Affiliation:
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Ehime University Hospital Dept. of Clinical pharmacology and Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: -Concomitant use of duloxetine within 2 weeks -Subject with contraindication to duloxetine -Suicidal ideation -Renal transplantation or dialysis therapy -History of any kidney diseases or baseline creatinine clearance below 30 (mL/min/1.73 m2) -Woman who are pregnant or lactating -Evidence of clinically significant disease - Subjects on antipsychotics -Have had multiple drug allergies or a severe drug reaction -History of drug or alcohol dependency or abuse -History of treatment with antipsychotics within 1 year before Visit 1 - Other inadequate status for clinical trial
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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PD patients
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Intervention(s)
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The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.
The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.
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Primary Outcome(s)
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Visual analogue scale
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Secondary Outcome(s)
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The short-form McGill Pain Questionnaire, Beck's Depression Scale, Parkinson's Disease Questionnaire-39, Unified Parkinson's Disease Rating Scale, Up and Go Test
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Source(s) of Monetary Support
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Shionogi & Co., Ltd.
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Ethics review
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Status: YES
Approval date: 28/01/2015
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/09/2019 |
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URL:
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