Trial · NCT01504412

Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy

NCT01504412, Phase 2, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2020-03-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy. Trials, record NCT01504412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01504412

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Trial

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

Title: Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
NCT number: NCT01504412
Status: Completed
Phases: Phase 2
Enrollment: 450 participants, actual
Lead sponsor: Daiichi Sankyo Co., Ltd.
Conditions: Pain, Diabetic Peripheral Neuropathy
Interventions: DS-5565, DS-5565, DS-5565, Placebo, Pregabalin capsules
First posted: 2012-01-05
Last updated: 2020-03-18
Results first posted: 2020-03-18

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	Baseline to Week 7 postdose	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.
Secondary	Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	at Week 7 postdose	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.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	Baseline to Week 7 postdose	Mean change in ADPS was assessed in the Full Analysis Set.	units on a scale	MEAN
SECONDARY	Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	at Week 7 postdose	Mean change in SF-MPQ VAS was assessed in the Full Analysis Set.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group40

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

Outcome	Group	Category	Value	Spread	Units
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	Placebo	Baseline to Week 1	-0.59	Standard Deviation 1.13	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	Pregabalin	Baseline to Week 1	-0.71	Standard Deviation 1.29	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	DS-5565 10 mg/Day	Baseline to Week 1	-0.69	Standard Deviation 0.90	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	DS-5565 20 mg/Day	Baseline to Week 1	-0.88	Standard Deviation 1.32	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	DS-5565 30 mg/Day	Baseline to Week 1	-0.60	Standard Deviation 1.01	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	Placebo	Baseline to Week 2	-0.86	Standard Deviation 1.36	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	Pregabalin	Baseline to Week 2	-0.92	Standard Deviation 1.33	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	DS-5565 10 mg/Day	Baseline to Week 2	-1.16	Standard Deviation 1.06	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	DS-5565 20 mg/Day	Baseline to Week 2	-1.21	Standard Deviation 1.56	units on a scale
Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	DS-5565 30 mg/Day	Baseline to Week 2	-1.06	Standard Deviation 1.28	units on a scale

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	89
Overall Study	STARTED	Pregabalin	87
Overall Study	STARTED	DS-5565 10 mg/Day	90
Overall Study	STARTED	DS-5565 20 mg/Day	94
Overall Study	STARTED	DS-5565 30 mg/Day	90
Overall Study	COMPLETED	Placebo	84
Overall Study	COMPLETED	Pregabalin	75
Overall Study	COMPLETED	DS-5565 10 mg/Day	86
Overall Study	COMPLETED	DS-5565 20 mg/Day	75
Overall Study	COMPLETED	DS-5565 30 mg/Day	77

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events100

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	Placebo	3	88
other	Nasopharyngitis	Infections and infestations	Pregabalin	2	86
other	Nasopharyngitis	Infections and infestations	DS-5565 10 mg/Day	7	90
other	Nasopharyngitis	Infections and infestations	DS-5565 20 mg/Day	13	93
other	Nasopharyngitis	Infections and infestations	DS-5565 30 mg/Day	3	90
other	Somnolence	Nervous system disorders	Placebo	5	88
other	Somnolence	Nervous system disorders	Pregabalin	12	86
other	Somnolence	Nervous system disorders	DS-5565 10 mg/Day	8	90
other	Somnolence	Nervous system disorders	DS-5565 20 mg/Day	13	93
other	Somnolence	Nervous system disorders	DS-5565 30 mg/Day	19	90

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	88
Total, all-cause mortality	Pregabalin	0	86
Total, all-cause mortality	DS-5565 10 mg/Day	0	90
Total, all-cause mortality	DS-5565 20 mg/Day	1	93
Total, all-cause mortality	DS-5565 30 mg/Day	0	90
Total, other adverse events	Placebo	13	88
Total, other adverse events	Pregabalin	28	86
Total, other adverse events	DS-5565 10 mg/Day	18	90
Total, other adverse events	DS-5565 20 mg/Day	38	93
Total, other adverse events	DS-5565 30 mg/Day	42	90

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32052264	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 comparisons0

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

None in this release.

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.

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