N/A
N=765
DS-5565 Phase III Study for Post-herpetic Neuralgia
Post-Herpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT02318719 ↗Enrolled (actual)
765
Serious AEs
2.0%
Results posted
Nov 2020
Primary outcome: Primary: Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia — -0.10; -0.39; -0.54; -0.46 units on a scale — p=0.0170
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo (Drug); DS-5565 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia |
-0.10; -0.39; -0.54; -0.46; -0.33; -0.72 | 0.0170 sig |
| SECONDARY Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia |
-0.70; 4.60; -8.30; -8.60; -8.70; -10.00 | — |
Summary
Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo
Eligibility Criteria
Inclusion Criteria
- PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening
- At screening, a pain scale of ≥ 40 mm
Exclusion Criteria
- Previous use of neurolytic block
Data sourced from ClinicalTrials.gov (NCT02318719). 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.