UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034468
Receipt number R000039263
Scientific Title Effect of pregabalin on neuropathic pain in Yusho patients: open label pilot study
Date of disclosure of the study information 2018/11/01
Last modified on 2021/04/21 10:41:02

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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 or person

Institute

Nagasaki University Hospital
Dermatology / Allergy Department

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039263


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name