Vertebrogenic Radiculopathy L5, S1 Clinical Trial
— NMRUSOfficial title:
Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
| Verified date | May 2017 |
| Source | Valeant Pharmaceuticals International, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | November 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | State Autonomous Institution Republican Clinical Centre of Neurology | Kazan | Republic of Tatarstan |
| Lead Sponsor | Collaborator |
|---|---|
| Valeant Pharmaceuticals International, Inc. | Valeant Russia, LLC |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change from Baseline in Systolic Blood Pressure at 10 Days | baseline and 10 days | ||
| Other | Change from Baseline in Systolic Blood Pressure at 3 weeks | baseline and 3 weeks | ||
| Other | Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks | baseline and 3 weeks | ||
| Other | Change from Baseline in Full Blood Count at 3 weeks | baseline and 3 weeks | ||
| Other | Change from Baseline in Urine Test at 3 weeks | baseline and 3 weeks | ||
| Primary | Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analogu? 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 | 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. | baseline and 3 weeks | |
| Secondary | 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. | baseline and 3 weeks | |
| Secondary | 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. | baseline and 3 weeks |