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Effect of NRD135S.E1 in Peripheral Neuropathic Pain in Diabetic Patients

NCT02345291 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-09-22

No results posted yet for this study

Summary

A multicenter, Phase 2a, randomized, double-blind, placebo (vehicle)-controlled, parallel-group, dose-finding study designed to evaluate the efficacy, safety and tolerability of NRD135S.E1 in adult patients with diabetes mellitus type 1 or 2 with neuropathic pain. Potential study patients will sign informed consent prior to undergoing any study-related procedure.

Conditions

  • Diabetic Peripheral Neuropathic Pain

Interventions

DRUG

NRD135S.E1

A small chemical entity for treatment of neuropathic pain NRD135S.E1

DRUG

Placebo to match NRD135S.E1

Placebo capsule to match NRD135S.E1 capsules

Sponsors & Collaborators

  • Novaremed Ltd.

    lead INDUSTRY

Principal Investigators

  • Eli Kaplan, MD · Novaremed Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Israel

Study Locations

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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 NCT02345291 on ClinicalTrials.gov