UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016893 |
|---|---|
| Receipt number | R000019588 |
| Scientific Title | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2019/04/22 10:31:28 |
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Basic information
Public title
A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression.
Acronym
Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine.
Scientific Title
A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression.
Scientific Title:Acronym
Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine.
Region
| Japan |
Condition
Condition
PD patients
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to demonstrate the efficacy of Duloxetine for pain associated with PD compared to placebo.
The secondary objective is to assess the improvement of Patients' quality of life, motor symptoms and mood by using Duloxetine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Visual analogue scale
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Diagnosed with Parkinson's disease
- Having pain associated with PD and depression.
-Provide written informed consent signed by the subject
Key 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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwaki |
Organization
Ehime University Hospital
Division name
Dept. of Clinical pharmacology and Neurology
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5095
h-iwaki@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwaki |
Organization
Ehime University Hospital
Division name
Dept. of Clinical pharmacology and Neurology
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5095
Homepage URL
h-iwaki@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Dept. of Clinical pharmacology and Neurology
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Enrolled to JRCT
https://jrct.niph.go.jp/detail/308/jRCT/1
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019588
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
