DS-5565 phase 3 study for renal impairment

Phase 3

Completed

• Conditions: Diabetic peripheral neuropathic pain, Post-herpetic neuralgia

• Registration Number: JPRN-jRCT2080223005
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

DS-5565 was safe and well tolerated in subjects with DPNP or PHN when used for 14 weeks, including 2-weeks' titration period, at a fixed dose of 7.5 mg BID for subjects with moderate RI and at a fixed dose of 7.5 mg QD for subjects with severe RI. DS-5565 reduced pain from baseline to Week 14 in subjects with DPNP or PHN and with moderate or severe RI.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-06
• Study Completion: 2017-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Patients with DPNP and patients with PHN:
-Average daily pain score >= 4
-Creatinine clearance (using Cockcroft-Gault equation): 15-59 mL/min at screening

Patients with DPNP only:
-Type 1 or Type 2 diabetes mellitus
-Painful distal symmetric polyneuropathy

Patients with PHN only:
-Post-herpetic neuralgia defined as pain present for more than 3 months after herpes zoster skin rash

Exclusion Criteria

For patients with DPNP only:
-HbA1c > 10.0%
-Uncontrolled blood glucose at screening at initiation of study treatment that may require changes in diabetes treatment (non-insulin drug therapy, exercise therapy, diet therapy) during the study
-Other severe pain at screening or initiation of study treatment, unrelated to diabetic peripheral neuropathy (DPN), that may confound the assessment of DPNP
-Neurologic disorders at screening or initiation of study treatment, unrelated to DPN, that may confound the assessment of DPNP

For patients with PHN only:
-Previous use of neurolytic block (eg, chemical neurolytic block using phenol or ethyl alcohol, radiofrequency thermocoagulation) or neurosurgical therapy for current PHN
-Other severe pain at screening or initiation of study treatment, unrelated to PHN, that may confound the assessment of PHN
-Neurologic disorders at screening or initiation of study treatment, unrelated to PHN, that may confound the assessment of PH

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>safety and tolerability

Secondary Outcome Measures

Name	Time	Method
efficacy<br>pharmacokinetics<br>Average Daily Pain Score