DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

Daiichi Sankyo Co., Ltd.854 enrolled

Overview

Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) 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 DPNP 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 DPNP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

854

Conditions

Diabetic Peripheral Neuropathic Pain

Interventions

DS-5565DRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetes mellitus at screening * Painful distal symmetric polyneuropathy * At screening, a pain scale of ≥ 40 mm Exclusion Criteria: * HbA1c (National Glycohemoglobin Standardization Program) \> 10.0%

Locations (1)

Saiki Central Hospital

Ōita, Japan

Outcomes

Primary Outcomes

Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain

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 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])

Secondary Outcomes

Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain

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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