Phase 3
N=35
DS-5565 Phase III Study for Renal Impairment in Japanese Subjects
Diabetic Peripheral Neuropathic Pain · Post-herpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT02607280 ↗Enrolled (actual)
35
Serious AEs
2.9%
Results posted
Oct 2020
Primary outcome: Primary: Change From Baseline in Average Daily Pain Score (ADPS) at Each Week — -0.14; -0.20; -0.37; -0.50 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DS-5565 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Daily Pain Score (ADPS) at Each Week |
-0.14; -0.20; -0.37; -0.50; -0.85; -1.83 | — |
Summary
Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.
Eligibility Criteria
Inclusion Criteria
- At screening, creatinine clearance (using the Cockcroft-Gault equation): 15-59 mL/min
- At screening, a pain scale of ≥ 40 mm
- Type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral neuropathic pain DPNP only)-. Painful distal symmetric polyneuropathy (for patients with DPNP only)
- post-herpetic neuralgia PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening (for patients with PHN only)
Exclusion Criteria
- HbA1c (National Glycohemoglobin Standardization Program) > 10.0% (for patients with DPNP only)
- Previous use of neurolytic block (for patients with PHN only)
Data sourced from ClinicalTrials.gov (NCT02607280). 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.