Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy (NMRUS)

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Vertebrogenic Radiculopathy L5, S1

Treatments: Drug: Sirdalud; Drug: Neuromultivit; Drug: Voltaren

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02508805

224

NM-01RUS

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Neuromultivit +Voltaren+Sirdalud

Experimental group

Description:

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.

Treatment:

Drug: Voltaren

Drug: Neuromultivit

Drug: Sirdalud

Voltaren+Sirdalud alone

Active Comparator group

Description:

Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days

Treatment:

Drug: Voltaren

Drug: Sirdalud