DS-5565 Phase III Study for Post-herpetic Neuralgia

Post-Herpetic Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318719
• Other study ID #: DS5565-A-J304
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: May 25, 2017

Study information

• Verified date: October 2020
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Post-Herpetic Neuralgia

Intervention

Drug:
• Placebo
Placebo
• DS-5565

Locations

Country	Name	City	State
Japan	Medical Corporation Fujigaki Clinic	Oita

Sponsors (3)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.	Quintiles, Inc., SRL Medisearch Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	Baseline to Week 14
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	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.	From baseline (Week 14) to Week 66