DS-5565 phase 2 study
Phase 2
Completed
- Conditions
- Pain associated with diabetic peripheral neuropathy
- Registration Number
- JPRN-jRCT2080221671
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
In subjects with pain associated with DPN receiving DS-5565 at a dose of 5 mg BID, 10 mg BID, or 15 mg BID for 7 weeks including 1-week titration, DS-5565 showed a numerically greater improvement in ADPS than placebo, although these differences versus placebo were not statistically significant for any treatment groups. DS-5565 was tolerated in this population at doses of 5 mg BID, 10 mg BID, and 15 mg BID.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Type 1 or type 2 diabetes mellitus
- Painful distal symmetric polyneuropathy
- Average daily pain score >=4
Exclusion Criteria
HbA1c (National Glycohemoglobin Standardization
Program) > 9.0%
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method