NIPH Clinical Trials Search

DS-5565 phase 3 study for renal impairment

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Diabetic peripheral neuropathic pain, Post-herpetic neuralgia
Date of first enrollment	21/01/2016
Target sample size	35
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : DS-5565 INN of investigational material : Mirogabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : Oral administration control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome	safety safety and tolerability
Secondary Outcome	efficacy pharmacokinetics Average Daily Pain Score

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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 PHN