DS-5565 Phase III Study for Post-herpetic Neuralgia

Overview

Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo

Full Title of Study: “An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Post-herpetic Neuralgia Followed by a 52-Week Open-label Extension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: May 25, 2017

Detailed Description

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian subjects with PHN receiving DS-5565 versus placebo. [Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with PHN.

Interventions

  • Drug: Placebo
    • Placebo
  • Drug: DS-5565

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo (14-weeks)
  • Experimental: DS-5565 15 mg Group
    • DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
  • Experimental: DS-5565 20 mg Group
    • DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose
  • Experimental: DS-5565 30 mg Group
    • DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: Baseline to Week 14
    • Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.

Secondary Measures

  • 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
    • Time Frame: From baseline (Week 14) to Week 66
    • Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as ‘no pain’ and 10 is defined as ‘worst possible pain’. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daiichi Sankyo Co., Ltd.
  • Collaborator
    • SRL Medisearch Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Leader, Study Director, Daichii Sankyo

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