NCT02508805

Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy

Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard therapy. The patients are randomised into two groups: standard therapy group and standard therapy plus Neuromultivit group.

Detailed description

Group 1 (50 patients) receive Neuromultivit (2 ml per day, i.m.) for 7 days, then -Neuromultivit (2 ml per day, i.m.) every other day for 10 days and standard therapy for 20 days. Group 2 (50 patients) receive only standard therapy for 20 days. Standard therapy involves: * Voltaren (100 mg prolonged-released film-coated tablets once daily) for 20 days * Sirdalud (2 mg tablets three times a day) for 20 days

Conditions

• Vertebrogenic Radiculopathy L5, S1

Interventions

Type	Name	Description
DRUG	Neuromultivit
DRUG	Voltaren
DRUG	Sirdalud

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2015-07-27
• Last updated: 2017-05-09

Locations

1 site across 1 country: Russia