DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

Phase 3

Completed

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Drug: DS-5565; Drug: placebo

• Registration Number: NCT02318706
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

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

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 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 Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-17
• Study Start: 2015-01
• Primary Completion: 2017-06-29
• Study Completion: 2017-06-29
• Results First Submitted: 2020-09-30
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Results First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 854

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DS-5565 15mg	DS-5565	DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
DS-5565 20 mg group	DS-5565	DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose
placebo	placebo	placebo group (14 weeks)
DS-5565 30 mg group	DS-5565	DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Primary Outcome Measures

Name	Time	Method
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	Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])	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 Outcome Measures

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

Trial Locations

Locations (1)

Saiki Central Hospital; 🇯🇵 Oita, Japan