NCT02508805

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

July 17, 2015

Last Update Submit

May 8, 2017

Conditions

Vertebrogenic Radiculopathy L5, S1

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale

    Self reported pain intensity over the last 24 hours. The amount of pain is marked on a horizontal line at a certain point which reflects pain perception best: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

    baseline and 3 weeks

Secondary Outcomes (3)

  • Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire

    baseline and 3 weeks

  • Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale

    baseline and 3 weeks

  • Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale

    baseline and 3 weeks

Other Outcomes (5)

  • Change from Baseline in Systolic Blood Pressure at 10 Days

    baseline and 10 days

  • Change from Baseline in Systolic Blood Pressure at 3 weeks

    baseline and 3 weeks

  • Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks

    baseline and 3 weeks

  • +2 more other outcomes

Study Arms (2)

Neuromultivit +Voltaren+Sirdalud

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.

Drug: NeuromultivitDrug: VoltarenDrug: Sirdalud

Voltaren+Sirdalud alone

ACTIVE COMPARATOR

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

Drug: VoltarenDrug: Sirdalud

Interventions

NeuromultivitDRUG
Neuromultivit +Voltaren+Sirdalud
VoltarenDRUG
Neuromultivit +Voltaren+SirdaludVoltaren+Sirdalud alone
SirdaludDRUG
Neuromultivit +Voltaren+SirdaludVoltaren+Sirdalud alone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • month exacerbation phase; nonuse of any B-group vitamins before the trial
  • negative urine pregnancy test; Patient Informed Consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Autonomous Institution Republican Clinical Centre of Neurology

Kazan', Tatarstan Republic, 420021, Russia

Location

MeSH Terms

Interventions

Diclofenactizanidine

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Farit Khabirov, MD, DSc, Prof

    State Autonomous Institution Republican Clinical Centre of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 27, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

RU(1)