DS-5565 Phase III Study for Post-herpetic Neuralgia

Daiichi Sankyo Co., Ltd.765 enrolled

Overview

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

\[Double Blind Phase\] 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

765

Conditions

Post-Herpetic Neuralgia

Interventions

PlaceboDRUG

Placebo

DS-5565DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Corporation Fujigaki Clinic

Ōita, Japan

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline to Week 14

Secondary Outcomes

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

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.

Time frame: From baseline (Week 14) to Week 66

Data from ClinicalTrials.gov

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