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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034468
Receipt No. 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 2018/10/12

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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
Middle name
Last name Murota Hiroyuki
Organization Nagasaki University Hospital
Division name Dermatology / Allergy Department
Zip code
Address 7-1 Sakamoto, Nagasakishi
TEL 0958197333
Email h-murota@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kamio Yoshiyuki
Organization Nagasaki University Hospital
Division name Dermatology / Allergy Department
Zip code
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
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
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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
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
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.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


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