Trial · NCT02607280

DS-5565 Phase III Study for Renal Impairment in Japanese Subjects

NCT02607280, Phase 3, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2020-10-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. DS-5565 Phase III Study for Renal Impairment in Japanese Subjects. Trials, record NCT02607280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02607280

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: DS-5565 Phase III Study for Renal Impairment in Japanese Subjects
NCT number: NCT02607280
Status: Completed
Phases: Phase 3
Enrollment: 35 participants, actual
Lead sponsor: Daiichi Sankyo Co., Ltd.
Conditions: Diabetic Peripheral Neuropathic Pain, Post-herpetic Neuralgia
Interventions: DS-5565
First posted: 2015-11-18
Last updated: 2021-05-13
Results first posted: 2020-10-26

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Baseline to Week 14	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Baseline to Week 14	ADPS was assessed in the All Enrolled Participants.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Moderate Renal Impairment	Week 1	-0.14	Standard Deviation 0.680	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Severe Renal Impairment	Week 1	-0.20	Standard Deviation 0.217	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Moderate Renal Impairment	Week 2	-0.37	Standard Deviation 0.940	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Severe Renal Impairment	Week 2	-0.50	Standard Deviation 0.937	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Moderate Renal Impairment	Week 3	-0.85	Standard Deviation 1.294	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Severe Renal Impairment	Week 3	-1.83	Standard Deviation 1.859	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Moderate Renal Impairment	Week 4	-1.13	Standard Deviation 1.318	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Severe Renal Impairment	Week 4	-2.07	Standard Deviation 2.375	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Moderate Renal Impairment	Week 5	-0.90	Standard Deviation 1.361	units on a scale
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Severe Renal Impairment	Week 5	-1.89	Standard Deviation 2.278	units on a scale

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Moderate Renal Impairment	30
Overall Study	STARTED	Severe Renal Impairment	5
Overall Study	Received Study Drug	Moderate Renal Impairment	30
Overall Study	Received Study Drug	Severe Renal Impairment	5
Overall Study	COMPLETED	Moderate Renal Impairment	26
Overall Study	COMPLETED	Severe Renal Impairment	4
Overall Study	NOT COMPLETED	Moderate Renal Impairment	4
Overall Study	NOT COMPLETED	Severe Renal Impairment	1

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Moderate Renal Impairment	6	30
other	Nasopharyngitis	Infections and infestations	Severe Renal Impairment	2	5
other	Somnolence	Nervous system disorders	Moderate Renal Impairment	4	30
other	Somnolence	Nervous system disorders	Severe Renal Impairment	0	5
other	Dizziness	Nervous system disorders	Moderate Renal Impairment	2	30
other	Dizziness	Nervous system disorders	Severe Renal Impairment	0	5
other	Sensory disturbance	Nervous system disorders	Moderate Renal Impairment	2	30
other	Sensory disturbance	Nervous system disorders	Severe Renal Impairment	0	5
other	Diarrhoea	Gastrointestinal disorders	Moderate Renal Impairment	2	30
other	Diarrhoea	Gastrointestinal disorders	Severe Renal Impairment	0	5

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Moderate Renal Impairment	0	30
Total, all-cause mortality	Severe Renal Impairment	0	5
Total, other adverse events	Moderate Renal Impairment	17	30
Total, other adverse events	Severe Renal Impairment	3	5
Total, serious adverse events	Moderate Renal Impairment	1	30
Total, serious adverse events	Severe Renal Impairment	0	5

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32765056	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Moderate Renal Impairment vs Severe Renal Impairment: deaths from any cause	Trial comparisons
Moderate Renal Impairment vs Severe Renal Impairment: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02607280

GET https://conductscience.org/api/trials/v1/NCT02607280/results?page=2

API reference For AI assistants