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| Name | Class |
|---|---|
| CMIC Co, Ltd. Japan | INDUSTRY |
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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.
The primary objective is the safety and tolerability of DS-5565 in Japanese subjects with moderate to severe renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-5565 group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-5565 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shonan Kamakura General Hospital | Kamakura-shi | Kanagawa | 247-8533 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32765056 | Derived | Baba M, Takatsuna H, Matsui N, Ohwada S. Mirogabalin in Japanese Patients with Renal Impairment and Pain Associated with Diabetic Peripheral Neuropathy or Post-Herpetic Neuralgia: A Phase III, Open-Label, 14-Week Study. J Pain Res. 2020 Jul 17;13:1811-1821. doi: 10.2147/JPR.S255345. eCollection 2020. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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A total of 35 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study from December 2015 to March 2017 at 1 clinic site in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Renal Impairment | Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks. |
| FG001 | Severe Renal Impairment | Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Renal Impairment | Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ADPS was assessed in the All Enrolled Participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 14 |
|
Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate Renal Impairment | Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2016 | Aug 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000598618 | mirogabalin |
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|
| Severe Renal Impairment |
Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks. |
| OG001 | Severe Renal Impairment | Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks. |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 17 |
| 30 |
| EG001 | Severe Renal Impairment | Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks. | 0 | 5 | 0 | 5 | 3 | 5 |
| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |