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

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title: A Phase 2a, Randomized, Double-blind, Placebo (Vehicle)-Controlled, Dose Finding Trial to Assess the Safety, Tolerability and Efficacy of NRD135S.E1 in Patients With Neuropathic Pain Associated With Diabetes Mellitus

Status Completed

Clinical Trial 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.

Clinical Trial Description

Following screening, eligible patients will be enrolled and go through a week of washout of analgesic treatment. Patients who are still eligible following the washout will be randomized to one of four treatment groups: NRD135S.E1 at 10, 40, or 150 mg per day or placebo (vehicle).

All four treatment groups will start study treatment with 1 week of single blind placebo (baseline week) followed by 3 weeks of the allocated double blind treatment (Weeks 1, 2, and 3). All patients will be followed for 30 days after the last study drug administration. The total study duration per patient is 9 to10 weeks.

Visit schedule: Screening (Days minus 14 to minus 8, Visit 1). Washout visit (Day minus 7, Visit 2). Randomization and start of placebo treatment (Day 1, Visit 3). Double blind treatment visits on Days 8 (Visit 4), 15 (Visit 5) and 29 (Visit 6). Follow up visit by telephone (Day 59, Visit 7). ;

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

• NCT number: NCT02345291
• Study type: Interventional
• Source: Novaremed Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Completion date: July 2016