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DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

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Daiichi Sankyo

Status and phase

Completed
Phase 3

Conditions

Diabetic Peripheral Neuropathic Pain

Treatments

Drug: placebo
Drug: DS-5565

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT02318706
DS5565-A-J303

Details and patient eligibility

About

Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo

Full description

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score(ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus placebo.

[Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with DPNP.

Enrollment

854 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 1 or type 2 diabetes mellitus at screening
  • Painful distal symmetric polyneuropathy
  • At screening, a pain scale of ≥ 40 mm

Exclusion criteria

  • HbA1c (National Glycohemoglobin Standardization Program) > 10.0%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

854 participants in 4 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
placebo group (14 weeks)
Treatment:
Drug: placebo
DS-5565 15mg
Experimental group
Description:
DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Treatment:
Drug: DS-5565
DS-5565 20 mg group
Experimental group
Description:
DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose
Treatment:
Drug: DS-5565
DS-5565 30 mg group
Experimental group
Description:
DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Treatment:
Drug: DS-5565

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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