ONO-2910-02: A Phase IIa Study of ONO-2910 in Patients with Diabetic Polyneuropathy
- Conditions
- Diabetic polyneuropathy
- Registration Number
- JPRN-jRCT2061210008
- Lead Sponsor
- Hirashima Yoshinori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 168
1. Type 2 diabetes with HbA1c : >= 6.5%, <= 10.0%
2. Patients diagnosised with diabetic polyneuropathy (DPN) by simplified diagnostic criteria for diabetic polyneuropathy proposed by the Conference on Diabetic Polyneuropathy
3. Patients suffering from Numbness and Tingling on both feet and their mTCNS score are >= 2 each.
1. Patients who are expected to change treatment methods (drug therapy, exercise therapy, etc.) for diabetes during the study period
2. Patients who are expected to newly take or change the dosage and administration of peripheral neuropathic pain medication, other analgesics, or agents for overall symptoms of DPN during the study period
3. Patients with pain or numbness other than DPN in upper or lower limbs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method