UMIN-CTR Clinical Trial

Basic information
Public title	Effect of pregabalin on neuropathic pain in Yusho patients: open label pilot study
Acronym	Effect of pregabalin on neuropathic pain in Yusho patients
Scientific Title	Effect of pregabalin on neuropathic pain in Yusho patients: open label pilot study
Scientific Title:Acronym	Effect of pregabalin on neuropathic pain in Yusho patients
Region	Japan

Condition
Condition	Yusho
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Pregabalin is a remedy for peripheral neuropathy such as postherpetic neuralgia. It has not been used against numbness and sensation deterioration of Yusho patients. There is no report that pregabalin is effective against numbness of Yusho patients, and it is verified by pilot test.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effect of pregabalin on sensory disorders such as numbness of the subjects is compared for each of VAS, Von frey, and heat sensation for each difference before pregabalin administration and at the end of administration (4th week after administration start).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	For the symptoms of numbness and sensation deterioration in Yusho patients, pregabalin 25 mg is orally administered for 4 weeks and the effect judgment is carried out and the result is analyzed. In addition, pregabalin should be administered in 4 weeks.
Interventions/Control_2
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who satisfy all the following criteria are targeted. 1.Age: patients aged 50 or older at the time of acquisition 2.Gender: No prejudice 3.Hospitalization / Outpatient: Outpatient only 4.After receiving sufficient explanation for participation in this study, patients who obtained document consent by the patient's free will with sufficient understanding. 5.Patient who is untreated for abnormal sensation of limbs or patient who is inadequate in current symptomatic treatment.
Key exclusion criteria	Patients applicable to even one of the following are excluded as subjects. 1.Patient currently taking pregabalin 2.Patients with serious liver and kidney dysfunction 3.Patients with drug hypersensitivity such as allergy to pregabalin 4.In addition, patients whose research managers judged inappropriate as research subjects
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Murota
Organization	Nagasaki University Hospital
Division name	Dermatology / Allergy Department
Zip code	852-8501
Address	7-1 Sakamoto, Nagasakishi
TEL	0958197333
Email	h-murota@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Yoshiyuki Middle name Last name Kamio
Organization	Nagasaki University Hospital
Division name	Dermatology / Allergy Department
Zip code	852-8501
Address	7-1 Sakamoto, Nagasakishi
TEL	095-819-7333
Homepage URL
Email	y-kamio@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital Dermatology / Allergy Department
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Hospital Clinical Research Ethics Committee
Address	7-1 Sakamoto, Nagasakishi
Tel	095-819-7229
Email	gaibushikin@ml.nagasaki-u.ac.jp

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	2018 Year 11 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	Terminated
Date of protocol fixation	2018 Year 10 Month 10 Day
Date of IRB	2019 Year 01 Month 22 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2020 Year 11 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 12 Day
Last modified on	2021 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039263