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

Primary Purpose

Vertebrogenic Radiculopathy L5, S1

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Neuromultivit
Voltaren
Sirdalud
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebrogenic Radiculopathy L5, S1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • State Autonomous Institution Republican Clinical Centre of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromultivit +Voltaren+Sirdalud

Voltaren+Sirdalud alone

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire
Self reported quality and intensity of pain, described by selecting 7 words, which reflect pain perception best, from 20 groups: three words from groups 1-10, two words from groups 11-15, a single word from group 16, one word from groups 17-20.
Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale
Self reported effect of pain on body functions and daily activities. The scores of responses to 19 questions (6 multiple choice questions and 13 single choice questions) are summed, yielding a total between 0 and 100 with higher values representing greater disability.
Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale
Self reported pain related functional limitations to 20 activities. The degree of difficulty in performing these daily activities is scored from 0-5 (0 = no effort, 5 = not able to), yielding a total between 0 and 100 with higher values representing greater disability.

Full Information

First Posted
July 17, 2015
Last Updated
May 8, 2017
Sponsor
Bausch Health Americas, Inc.
Collaborators
Valeant Russia, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02508805
Brief Title
Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy
Acronym
NMRUS
Official Title
Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Valeant Russia, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebrogenic Radiculopathy L5, S1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromultivit +Voltaren+Sirdalud
Arm Type
Experimental
Arm 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.
Arm Title
Voltaren+Sirdalud alone
Arm Type
Active Comparator
Arm Description
Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days
Intervention Type
Drug
Intervention Name(s)
Neuromultivit
Intervention Type
Drug
Intervention Name(s)
Voltaren
Intervention Type
Drug
Intervention Name(s)
Sirdalud
Primary Outcome Measure Information:
Title
Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale
Description
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).
Time Frame
baseline and 3 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire
Description
Self reported quality and intensity of pain, described by selecting 7 words, which reflect pain perception best, from 20 groups: three words from groups 1-10, two words from groups 11-15, a single word from group 16, one word from groups 17-20.
Time Frame
baseline and 3 weeks
Title
Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale
Description
Self reported effect of pain on body functions and daily activities. The scores of responses to 19 questions (6 multiple choice questions and 13 single choice questions) are summed, yielding a total between 0 and 100 with higher values representing greater disability.
Time Frame
baseline and 3 weeks
Title
Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale
Description
Self reported pain related functional limitations to 20 activities. The degree of difficulty in performing these daily activities is scored from 0-5 (0 = no effort, 5 = not able to), yielding a total between 0 and 100 with higher values representing greater disability.
Time Frame
baseline and 3 weeks
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Systolic Blood Pressure at 10 Days
Time Frame
baseline and 10 days
Title
Change from Baseline in Systolic Blood Pressure at 3 weeks
Time Frame
baseline and 3 weeks
Title
Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks
Time Frame
baseline and 3 weeks
Title
Change from Baseline in Full Blood Count at 3 weeks
Time Frame
baseline and 3 weeks
Title
Change from Baseline in Urine Test at 3 weeks
Time Frame
baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farit Khabirov, MD, DSc, Prof
Organizational Affiliation
State Autonomous Institution Republican Clinical Centre of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Autonomous Institution Republican Clinical Centre of Neurology
City
Kazan
State/Province
Republic of Tatarstan
ZIP/Postal Code
420021
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy

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