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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016893
Receipt No. 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

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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
Email 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
Email h-iwaki@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Hospital
Dept. of Clinical pharmacology and Neurology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019588

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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