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
Verified date | April 2021 |
Source | Daiichi Sankyo, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Japan | Shonan Kamakura General Hospital | Kamakura-shi | Kanagawa |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Co., Ltd. | CMIC Co, Ltd. Japan |
Japan,
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 |
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