Unique ID issued by UMIN | UMIN000034468 |
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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 |
Effect of pregabalin on neuropathic pain in Yusho patients: open label pilot study
Effect of pregabalin on neuropathic pain in Yusho patients
Effect of pregabalin on neuropathic pain in Yusho patients: open label pilot study
Effect of pregabalin on neuropathic pain in Yusho patients
Japan |
Yusho
Dermatology |
Others
NO
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.
Efficacy
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).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
50 | years-old | <= |
Not applicable |
Male and Female
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.
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
20
1st name | Hiroyuki |
Middle name | |
Last name | Murota |
Nagasaki University Hospital
Dermatology / Allergy Department
852-8501
7-1 Sakamoto, Nagasakishi
0958197333
h-murota@nagasaki-u.ac.jp
1st name | Yoshiyuki |
Middle name | |
Last name | Kamio |
Nagasaki University Hospital
Dermatology / Allergy Department
852-8501
7-1 Sakamoto, Nagasakishi
095-819-7333
y-kamio@nagasaki-u.ac.jp
Nagasaki University Hospital
Dermatology / Allergy Department
None
Self funding
Nagasaki University Hospital Clinical Research Ethics Committee
7-1 Sakamoto, Nagasakishi
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
NO
2018 | Year | 11 | Month | 01 | Day |
Unpublished
Terminated
2018 | Year | 10 | Month | 10 | Day |
2019 | Year | 01 | Month | 22 | Day |
2018 | Year | 12 | Month | 01 | Day |
2020 | Year | 11 | Month | 16 | Day |
2018 | Year | 10 | Month | 12 | Day |
2021 | Year | 04 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039263
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