Vertebrogenic Radiculopathy L5, S1Phase 3NMRUSNCT02508805
Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy
A Phase 3 study testing Neuromultivit, Voltaren and Sirdalud in people with Vertebrogenic Radiculopathy L5, S1, run by Bausch Health Americas, Inc. at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vertebrogenic Radiculopathy L5, S1
- What is being tested?
- Neuromultivit, Voltaren and Sirdalud
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- May 2015to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Russia1 site
State Autonomous Institution Republican Clinical Centre of Neurology
Kazan', Tatarstan Republic, 420021
About this study
Official title: Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
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.
Read the 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
- Conditions
- Vertebrogenic Radiculopathy L5, S1
- Being tested
- Neuromultivit, Voltaren, Sirdalud
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromultivitDrug
VoltarenDrug
SirdaludDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Neuromultivit; Drug: Voltaren; Drug: 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 Receives: Drug: Voltaren; Drug: Sirdalud |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline and 3 weeks
Secondary outcomes (3)
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.
Measured: baseline and 3 weeks
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.
Measured: baseline and 3 weeks
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.
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebrogenic Radiculopathy L5, S1Studies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Valeant Russia, LLC
- Responsible party
- Sponsor
- Investigators
- Farit Khabirov, MD, DSc, Prof, Principal investigator, State Autonomous Institution Republican Clinical Centre of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508805
- Sponsor's protocol ID
- NM-01RUS
- Other IDs
- 224
- Acronym
- NMRUS
- Status last verified
- May 2017
- First submitted
- 17 Jul 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
- ClinicalTrials.gov ID
- NCT02508805
- Acronym / sponsor ID
- NMRUS / NM-01RUS
- Conditions
- Vertebrogenic Radiculopathy L5, S1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Valeant Russia, LLC
- Study start
- May 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromultivit +Voltaren+Sirdalud | Experimental | Drug: Neuromultivit, Drug: Voltaren, Drug: SirdaludNeuromultivit 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+Sirdalud alone | Active comparator | Drug: Voltaren, Drug: SirdaludVoltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromultivit | Drug | Neuromultivit +Voltaren+Sirdalud |
| Voltaren | Drug | Neuromultivit +Voltaren+Sirdalud, Voltaren+Sirdalud alone |
| Sirdalud | Drug | Neuromultivit +Voltaren+Sirdalud, Voltaren+Sirdalud alone |
Primary outcome
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).
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farit Khabirov, MD, DSc, Prof principal investigator
State Autonomous Institution Republican Clinical Centre of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neuromultivit, Voltaren and Sirdalud in people with Vertebrogenic Radiculopathy L5, S1, run by Bausch Health Americas, Inc. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale (time frame: baseline and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.