Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-25 @ 1:53 AM
Study NCT ID:
NCT02508805
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2015-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy
Sponsor:
Bausch Health Americas, Inc.
Organization:
Study Overview
Official Title:
Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NMRUS
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 224 | REGISTRY | registration study | View |