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

NCT01504412 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2020-03-18

Study results available
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Summary

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.

Conditions

  • Pain
  • Diabetic Peripheral Neuropathy

Interventions

DRUG

DS-5565

Oral tablets administered twice daily

DRUG

DS-5565

Oral tablets administered twice daily

DRUG

DS-5565

Oral tablets administered twice daily

DRUG

Placebo

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

DRUG

Pregabalin capsules

Pregabalin oral capsules 150 mg administered twice a day

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504412 on ClinicalTrials.gov