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The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-5565 Low Dose | Experimental | DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. |
|
| DS-5565 Middle Dose | Experimental | DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. |
|
| DS-5565 High Dose | Experimental | DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. |
|
| Placebo | Placebo Comparator | DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. |
|
| Pregabalin | Active Comparator | Pregabalin capsules 300mg/day administered in 2 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-5565 | Drug | Oral tablets administered twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy | The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point [scale of 0 to 10] versus placebo. | Baseline to Week 7 postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy | The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Greater mean changes (improvements) in SF-MPQ indicated better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32052264 | Derived | Baba M, Kuroha M, Ohwada S, Murayama E, Matsui N. Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study. Pain Ther. 2020 Jun;9(1):261-278. doi: 10.1007/s40122-020-00156-6. Epub 2020 Feb 12. |
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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.
Enrolled participants were equally randomized (1:1:1:1:1) to placebo, pregabalin, or one of three different doses of DS-5565 in a double-blind fashion. After randomization, participants received one-half the fixed dose for the first week, and subsequently received the fixed dose for 6 weeks. All participants were followed for an additional week.
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled and randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. |
| FG001 | Pregabalin | Pregabalin capsules 300 mg/day administered in 2 doses |
| FG002 | DS-5565 10 mg/Day | DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily). |
| FG003 | DS-5565 20 mg/Day | DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily). |
| FG004 | DS-5565 30 mg/Day | DS-5565 30mg/day, administered in 2 doses (15 mg twice daily). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. |
| BG001 | Pregabalin | Pregabalin capsules 300 mg/day administered in 2 doses |
| 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 | Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy | The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point [scale of 0 to 10] versus placebo. | Mean change in ADPS was assessed in the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 7 postdose |
|
Adverse event data were collected from the time the Informed Consent Form was signed to 7 days after the last dose of study medication, approximately 18 months.
Adverse events that appeared for the first time during treatment, or that worsened relative to the pre-treatment state, were analyzed. Additionally, 3 participants who had major violations of GCP were excluded from the Safety Analysis Set (1 participant each in the placebo, pregabalin, and in the 20-mg/day group).
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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 | Placebo | DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo, Inc. | +81 362251111 (M-F 9-5 JST) | dsclinicaltrial@daiichisankyo.co.jp |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000598618 | mirogabalin |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| DS-5565 |
| Drug |
Oral tablets administered twice daily |
|
| DS-5565 | Drug | Oral tablets administered twice daily |
|
| Placebo | Drug | DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day |
|
| Pregabalin capsules | Drug | Pregabalin oral capsules 150 mg administered twice a day |
|
| at Week 7 postdose |
| Seoul |
| South Korea |
| Taipei | Taiwan |
| Withdrawal by Subject |
|
| Other |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Death |
|
| BG002 | DS-5565 10 mg/Day | DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily). |
| BG003 | DS-5565 20 mg/Day | DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily). |
| BG004 | DS-5565 30 mg/Day | DS-5565 30mg/day, administered in 2 doses (15 mg twice daily). |
| BG005 | 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 |
|
| OG001 | Pregabalin | Pregabalin capsules 300 mg/day administered in 2 doses |
| OG002 | DS-5565 10 mg/Day | DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily). |
| OG003 | DS-5565 20 mg/Day | DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily). |
| OG004 | DS-5565 30 mg/Day | DS-5565 30mg/day, administered in 2 doses (15 mg twice daily). |
|
|
|
| Secondary | Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy | The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Greater mean changes (improvements) in SF-MPQ indicated better outcomes. | Mean change in SF-MPQ VAS was assessed in the Full Analysis Set. | Posted | Mean | Standard Error | units on a scale | at Week 7 postdose |
|
|
|
|
| 0 |
| 88 |
| 3 |
| 88 |
| 13 |
| 88 |
| EG001 | Pregabalin | Pregabalin capsules 300 mg/day administered in 2 doses | 0 | 86 | 2 | 86 | 28 | 86 |
| EG002 | DS-5565 10 mg/Day | DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose. | 0 | 90 | 1 | 90 | 18 | 90 |
| EG003 | DS-5565 20 mg/Day | DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose. | 1 | 93 | 4 | 93 | 38 | 93 |
| EG004 | DS-5565 30 mg/Day | DS-5565 30mg/day, administered in 2 doses (15 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose. | 0 | 90 | 2 | 90 | 42 | 90 |
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Metastases to lymph node | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| ANCOVA |
| 0.0577 |
| Least squares mean difference |
| -5.4 |
| 2-Sided |
| 95 |
| -10.9 |
| 0.2 |
| Superiority |
| This analysis assessed placebo vs DS-5565 30 mg/day for the visual analog scale. | ANCOVA | 0.0093 | Least squares mean difference | -7.4 | 2-Sided | 95 | -13.0 | -1.8 | Superiority |