UMIN-CTR Clinical Trial

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
Last 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
1st 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