NCT02345291

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Novaremed Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-01-26
• Last updated: 2016-09-22

Locations

10 sites across 1 country: Israel