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

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ClinicalTrials.gov Identifier: NCT02508805
Recruitment Status : Completed
First Posted : July 27, 2015
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
Valeant Russia, LLC
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

Condition or disease Intervention/treatment Phase
Vertebrogenic Radiculopathy L5, S1 Drug: Neuromultivit Drug: Voltaren Drug: Sirdalud Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
Actual Study Start Date : May 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neuromultivit +Voltaren+Sirdalud

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: Neuromultivit
Drug: Voltaren
Drug: Sirdalud
Active Comparator: Voltaren+Sirdalud alone
Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days
Drug: Voltaren
Drug: Sirdalud



Primary Outcome Measures :
  1. Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale [ Time Frame: baseline and 3 weeks ]
    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 :
  1. Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire [ Time Frame: baseline and 3 weeks ]
    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.

  2. Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale [ Time Frame: baseline and 3 weeks ]
    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.

  3. Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale [ Time Frame: baseline and 3 weeks ]
    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.


Other Outcome Measures:
  1. Change from Baseline in Systolic Blood Pressure at 10 Days [ Time Frame: baseline and 10 days ]
  2. Change from Baseline in Systolic Blood Pressure at 3 weeks [ Time Frame: baseline and 3 weeks ]
  3. Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks [ Time Frame: baseline and 3 weeks ]
  4. Change from Baseline in Full Blood Count at 3 weeks [ Time Frame: baseline and 3 weeks ]
  5. Change from Baseline in Urine Test at 3 weeks [ Time Frame: baseline and 3 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508805


Locations
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Russian Federation
State Autonomous Institution Republican Clinical Centre of Neurology
Kazan, Republic of Tatarstan, Russian Federation, 420021
Sponsors and Collaborators
Bausch Health Americas, Inc.
Valeant Russia, LLC
Investigators
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Principal Investigator: Farit Khabirov, MD, DSc, Prof State Autonomous Institution Republican Clinical Centre of Neurology

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02508805     History of Changes
Other Study ID Numbers: NM-01RUS
224 ( Registry Identifier: registration study )
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diclofenac
Clonidine
Tizanidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Sympatholytics