Overview

This trial is active, not recruiting.

Condition vertebrogenic radiculopathy l5, s1
Treatments neuromultivit, voltaren, sirdalud
Phase phase 3
Sponsor Valeant Pharmaceuticals International, Inc.
Collaborator Valeant Russia, LLC
Start date May 2015
End date September 2015
Trial size 100 participants
Trial identifier NCT02508805, 224, NM-01RUS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Neuromultivit 2ml i.m. once a day for 7 days, then 2 ml i.m. one time every other day for 10 days. Voltaren 100mg per os once a day for 20 days. Sirdalud 2 mg per os three times a day for 20 days.
neuromultivit
voltaren
sirdalud
(Active Comparator)
Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days
voltaren
sirdalud

Primary Outcomes

Measure
Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale
time frame: baseline and 3 weeks

Secondary Outcomes

Measure
Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire
time frame: baseline and 3 weeks
Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale
time frame: baseline and 3 weeks
Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale
time frame: baseline and 3 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - diagnosed vertebrogenic radiculopathy L5, S1 - radicular pain syndrome - changes in the low back CT and MRI scans - minimum 40 mm intensity of spontaneous back pain, rated on the VA scale - 1 month exacerbation phase; nonuse of any B-group vitamins before the trial - negative urine pregnancy test; Patient Informed Consent Exclusion Criteria: - tumors, inflammatory infections, any neurological diseases, imitating the symptoms of radiculopathy - concomitant life-threatening medical conditions - simultaneous administration of acetylsalicylic acid, levodopa, prednisolone; any psychiatric diseases - epilepsy, alcohol and drug addiction - pregnancy and breast-feeding - any condition preventing CT and MRI tests, including obesity and special devices - participation in any other clinical study 1 month before enrollment.

Additional Information

Official title Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
Principal investigator Farit Khabirov, MD, DSc, Prof
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Valeant Pharmaceuticals International, Inc..