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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02607280
Other study ID # DS5565-A-J313
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
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