DS-5565 Phase III Study for Renal Impairment in Japanese Subjects

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

A JAPANESE, PHASE 3, OPEN-LABEL, 14-WEEK STUDY OF DS-5565 IN PATIENTS WITH PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY WITH RENAL IMPAIRMENT OR POST-HERPETIC NEURALGIA WITH RENAL IMPAIRMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607280
• Other study ID #: DS5565-A-J313
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2021
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.

Description:

The primary objective is the safety and tolerability of DS-5565 in Japanese subjects with moderate to severe renal impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• At screening, creatinine clearance (using the Cockcroft-Gault equation): 15-59 mL/min
• At screening, a pain scale of = 40 mm
• Type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral neuropathic pain DPNP only)-. Painful distal symmetric polyneuropathy (for patients with DPNP only)
• post-herpetic neuralgia PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening (for patients with PHN only)

Exclusion Criteria:

• HbA1c (National Glycohemoglobin Standardization Program) > 10.0% (for patients with DPNP only)
• Previous use of neurolytic block (for patients with PHN only)

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia
• Neuralgia, Postherpetic
• Post-herpetic Neuralgia
• Renal Insufficiency

Intervention

Drug:
• DS-5565
DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Locations

Country	Name	City	State
Japan	Shonan Kamakura General Hospital	Kamakura-shi	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.	CMIC Co, Ltd. Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	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