Phase 2
Completed N=450
Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
Source: ClinicalTrials.gov NCT01504412 ↗Enrolled (actual)
450
Serious AEs
2.7%
Results posted
Mar 2020
Primary outcomePrimary: Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy — -0.59; -0.71; -0.69; -0.88 units on a scale — p=0.1995
Summary
The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy |
-0.59; -0.71; -0.69; -0.88; -0.60; -0.86 | 0.1995 |
| SECONDARY Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy |
-16.7; -17.2; -21.9; -22.1; -24.2 | 0.0691 |
Eligibility Criteria
Inclusion Criteria
- Type 1 or Type 2 diabetes mellitus
- Painful distal symmetric polyneuropathy
- Average daily pain score is great than or equal to 4
Exclusion Criteria
- HbA1c greater than 9.0
Data sourced from ClinicalTrials.gov (NCT01504412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.