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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Pain; Diabetic Peripheral Neuropathy

Treatments: Drug: Placebo; Drug: Pregabalin capsules; Drug: DS-5565

Study type: Interventional

Funder types: Industry

Identifiers

NCT01504412

DS5565-A-J202

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or Type 2 diabetes mellitus
• Painful distal symmetric polyneuropathy
• Average daily pain score is great than or equal to 4

Exclusion criteria

• HbA1c greater than 9.0

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 5 patient groups, including a placebo group

DS-5565 Low Dose

Experimental group

Description:

DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.

Treatment:

Drug: DS-5565

Drug: DS-5565

Drug: DS-5565

DS-5565 Middle Dose

Experimental group

Description:

DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.

Treatment:

Drug: DS-5565

Drug: DS-5565

Drug: DS-5565

DS-5565 High Dose

Experimental group

Description:

DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.

Treatment:

Drug: DS-5565

Drug: DS-5565

Drug: DS-5565

Placebo

Placebo Comparator group

Description:

DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.

Treatment:

Drug: Placebo

Pregabalin

Active Comparator group

Description:

Pregabalin capsules 300mg/day administered in 2 doses

Treatment:

Drug: Pregabalin capsules