Unique ID issued by UMIN | UMIN000029717 |
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Receipt number | R000033869 |
Scientific Title | Evaluation of pregabalin external use preparation for diabetic polyneuropathy |
Date of disclosure of the study information | 2017/10/26 |
Last modified on | 2019/02/20 13:58:31 |
Evaluation of pregabalin external use preparation for diabetic polyneuropathy
Evaluation of pregabalin external use preparation
Evaluation of pregabalin external use preparation for diabetic polyneuropathy
Evaluation of pregabalin external use preparation
Japan |
diabetic polyneuropathy
Medicine in general | Endocrinology and Metabolism | Neurology |
Adult |
Others
NO
The aim of this study is evaluation of the efficacy and safety of pregabalin 5% cream for pain due to diabetic polyneuropathy
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Changes amount at 8 weeks from the baseline of the average pain score
Changes in VAS pain score from baseline measured using short version McGill pain questionnaire (SF-MPQ)
Changes in QOL score from baseline assessed with SF-8
Changes in drowsiness score from baseline assessed with ESS Japanese version
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
pregabalin 5% cream 1 g each time for one foot, twice daily application
20 | years-old | <= |
Not applicable |
Male and Female
1) Adults (20 years or higher)
2) Patients who have the ability to agree, observe compliance matters while participating in the study, understand the procedure prescribed in this study plan, and can respond appropriately to all questionnaires
3) Patients with diabetic polyneuropathy(DPN) in the lower limbs during diabetes treatment
4) Patients with visual analog scale (VAS) pain score 20 mm or higher measred using the Short-Form McGill Pain Questionnaire (SF-MPQ) at screening
5) Patients who are judged eligible for study entry in the preliminary exam described in this study protocol
1)Patients with visual analog scale (VAS) pain score 90 mm or higher measred using the Short-Form McGill Pain Questionnaire (SF-MPQ) at screening
2) Patients who have any other severe pain unrelated to DPN which may affect the evaluation of the efficacy at screening
3) Patients with serious mental disorders at screening
4) Patients who took medication for neuropathic pain within 14 days before screening
5) Patients who has a history of allergies to medication or has a unique constitution (alcohol hypersensitivity etc.)
6) Pregnant women, lactating women
7) Those within 3 months from participation in other clinical trials
8) Others who have judged that the research responsible doctor or the research sharing doctor is inappropriate as the object of this research
3
1st name | |
Middle name | |
Last name | Takeshi Yamamoto |
School of Medicine, Showa University
Division of Diabetes and Endocrinology, Department of Internal Medicine
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
03-3784-8000
tak3105@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Masayuki Yoshikawa |
Showa University East Hospital
Pharmacy
2-14-9 Nishinakanobu, Shinagawa-ku, Tokyo, Japan
03-3784-8308
masayuki-y@cmed.showa-u.ac.jp
School of pharmacy, Showa University
NO
Self funding
Department of Pharmacotherapeutics, Division of Pharmacokinetics and Pharmacodynamics
Showa University School of Pharmacy
NO
昭和大学病院附属東病院 Showa University East Hospital
2017 | Year | 10 | Month | 26 | Day |
Unpublished
Terminated
2017 | Year | 10 | Month | 20 | Day |
2017 | Year | 10 | Month | 21 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2017 | Year | 10 | Month | 26 | Day |
2019 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033869
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