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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-jRCTs061180028 |
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Date of registration:
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26/02/2019 |
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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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Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine
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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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11/05/2015 |
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Target sample size:
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50 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs061180028 |
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Study type:
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Interventional |
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Study design:
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randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose
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Phase:
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2
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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 454, Toon, Ehime
7910295
Ehime
Japan |
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Telephone:
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+81-899605095 |
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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 |
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Name:
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Rina
Ando |
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Address:
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Sitsukawa 454, Toon, Ehime
791-0295
Ehime
Japan |
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Telephone:
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+81-89-960-5095 |
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Email:
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ando.rina.cn@ehime-u.ac.jp |
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Affiliation:
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Ehime University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Male or Female, 20 years old or older
- Diagnosed with Parkinson's disease
- Having pain associated with PD and depression.
-Provide written informed consent signed by the subject
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:
20 years old
Age maximum:
None
Gender:
Both
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Health Condition(s) or Problem(s) studied
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D010300
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Parkinson's disease
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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.
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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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Secondary ID(s)
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UMIN000016893
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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: Approval
Approval date:
Contact:
rinri@m.ehime-u.ac.jp
Certified Review Board, Ehime University
+81-89-960-5172
rinri@m.ehime-u.ac.jp
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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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01/10/2019 |
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Date Completed:
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20/08/2019 |
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URL:
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