diabetic polyneuropathy
Conditions
Interventions
pregabalin 5% cream 1 g each time for one foot, twice daily application
Sponsors
School of pharmacy, Showa University
Department of Pharmacotherapeutics, Division of Pharmacokinetics and Pharmacodynamics Showa University School of Pharmacy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes amount at 8 weeks from the baseline of the average pain score | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMasayuki Yoshikawa
Showa University East Hospital Pharmacy
Outcome results
None listed