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Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

NCT01496365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2021-01-05

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DRUG

DS-5565 tablet

5mg and 10mg tablets

DRUG

pregabalin capsule

75mg and 150mg over-encapsulated

DRUG

Placebo tablet

DRUG

placebo capsule

Sponsors & Collaborators

Principal Investigators

  • Domenico Merante, MD · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-28
Primary Completion
2012-09-07
Completion
2012-09-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01496365 on ClinicalTrials.gov