DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

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

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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