Milgamma® and Milgamma® Compositum Step-therapy in Patients With Acute Non-specific Low Back Pain Receiving Modern NSAID

NCT03892707 | Completed Results

• 1 other identifier: WP-RU-2018/1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 21

Brief Summary

The purpose of this study is to assess the effectiveness and safety of add-on Milgamma®/ Milgamma® compositum step-therapy in patients with acute non-specific low back pain receiving modern NSAIDs in routine medical practice.

Conditions

Acute Non-specific Low Back Pain

Keywords

Low back pain; Milgamma; NSAIDs

Outcome Measures

Primary Outcomes (1)

• Change of Pain Intensity After 10 Days of Treatment

  Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Pain intensity was measured at baseline and at 10 days after the start of treatment.

  Baseline; Visit 3 (10 days after the start of treatment)

Secondary Outcomes (13)

• Change of Pain Intensity After 5, 24 and 38 Days of Treatment

  Baseline; Visit 2 (5 days after the start of treatment), Visit 4 (24 days after the start of treatment); Visit 5 (38 days after the start of treatment)

• Change of Pain Intensity Over Time

  From Baseline to Visit 5 (38 days after the start of treatment)

• Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment.

  Visit 2 (5 days after the start of treatment); Visit 3 (10 days after the start of treatment); Visit 4 (24 days after the start of treatment) and Visit 5 (38 days after the start of treatment)

• Change in Pain-related Disability After 10 Days of Treatment

  Baseline; Visit 3 (10 days after the start of treatment)

• Percentage of Patients With at Least One Pain Flare-up During the Study

  From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)

Study Arms (2)

NSAIDs group

Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors)

NSAIDs+Milgamma+Milgamma compositum group

Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum

Drug: Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositum

Interventions

Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositum DRUG

Milgamma®: 2 mL injection solution containing thiamin hydrochloride 100 mg, pyridoxine hydrochloride 100 mg, cyanocobalamin 1 mg, lidocaine hydrochloride 20 mg. Milgamma® compositum: 1 tablet containing benfotiamine 100 mg, pyridoxine hydrochloride 100 mg.

Also known as: Non-Steroidal Anti-Inflammatory Drugs (celecoxib, etoricoxib, meloxicam, nimesulide)

NSAIDs+Milgamma+Milgamma compositum group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult out-patients will be enrolled by neurologists in clinical sites all over the Russian Federation.

You may qualify if:

• Signed informed consent including data protection declaration according to the local legislation.
• Acute non-specific low back pain less than 21 days (= 3 weeks).
• Low back pain treatment with (1) modern NSAIDs (preferential/selective COX-2 inhibitors) or (2) modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma®/ Milgamma® compositum prescribed (but not started yet) in frames of routine medical practice.
• Prescribed (but not started yet) step-therapy with Milgamma® to be followed by Milgamma® compositum in accordance with locally approved instruction for medical use (for the group planned to be treated with Milgamma®/ Milgamma® compositum step-therapy).
• Pain intensity according to Numerical Rating Scale (NRS) ≥4 points ≤9 at the time of enrollment.
• In case of presence of previous episodes of acute non-specific low back pain in medical history, the last one had resolved at least 30 days before the start of current episode.

You may not qualify if:

• History or presence of any disease that, in the opinion of the investigator, might confound the results of the study, poses an additional risk to the subject during participation in the study or can change pain perception (examples of such possible conditions: any malignancy, stomach ulcer, duodenal ulcer, chronic heart failure, bronchial asthma, psychiatry disorders, epilepsy, Parkinson Disease etc).
• Spinal surgery/rehabilitation in the last 12 months.
• Acute back pain that is attributable to any known or suspected specific identifiable cause (e.g. discogenic radiculopathy, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumor).
• Severe scoliosis.
• Use of NSAIDs or vitamins B within 2 months prior to enrollment into the study.
• Necessity to use myorelaxants or antidepressants for treatment of acute non-specific low back pain.
• Prior use of non-pharmacological treatment (physiotherapy, heat treatment (e.g. heat patch, hot water bottle) or topically applied medicinal products to the back area, procaine blocks) within the last 3 days before study entry.

Sponsors & Collaborators

• Woerwag Pharma LLC: lead

Study Sites (21)

LLC Medical Center "Nebolit"

Mytishchi, Moscow Oblast, Russia

Location

LLC "Research Medical Complex "Vashe Zdorovie"

Kazan', Russia

Location

State Healthcare Institution "Republican Clinical Neurological Center"

Kazan', Russia

Location

Regional State Budgetary Institution of Health "Regional Clinical Hospital № 1" named after Prof. S.I. Sergeev

Khabarovsk, Russia

Location

Federal State Healthcare Institution "Russian Scientific Center of Surgery named after academician B.V. Petrovsky"

Moscow, Russia

Location

LLC "Medicina"

Moscow, Russia

Location

Non-state Healthcare Institution "Central Clinical Hospital No. 2 named after N.A. Semashko of the JSC Russian Railways

Moscow, Russia

Location

LLC "Clinical Diagnostic Center Avitsena"

Naberezhnye Chelny, Russia

Location

LLC "Licon Plus"

Naberezhnye Chelny, Russia

Location

LLC "Medis"

Nizhny Novgorod, Russia

Location

JSC "MEdical Center Avitsenna", group of companies "Mother and Child"

Novosibirsk, Russia

Location

LLC "MRI-Expert Novosibirsk"

Novosibirsk, Russia

Location

LLC "Multidisciplinary center of modern medicine "Euromed"

Omsk, Russia

Location

Federal State Healthcare Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences

Saint Petersburg, Russia

Location

Out-patient clinic of SUE St. Petersburg Metropoliten

Saint Petersburg, Russia

Location

LLC "MD Project 2010"

Ufa, Russia

Location

LLC "National Medical Holding Medstandart"

Ufa, Russia

Location

Volgograd State Medical University

Volgograd, Russia

Location

LLC "Center of Evidence-Based Medicine"

Yaroslavl, Russia

Location

State Healthcare Institution of Yaroslavl Region "Clinical Hospital №8"

Yaroslavl, Russia

Location

LLC "Center for Medical Prevention and Rehabilitation treatment "Kamkor"

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Celecoxib; Etoricoxib; Meloxicam; nimesulide

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Thiazines; Thiazoles

Results Point of Contact

• Title: Anna Shagako, Clinical Trials Manager/ Authorized Person of Pharmacovigilance
• Organization: Woerwag Pharma LLC

anna.shagako@woerwagpharma.ru

+7 (495) 382 85 56

Study Officials

• Vladimir Parfenov

  I.M. Sechenov First Moscow State Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 27, 2019
• Study Start: December 15, 2018
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: October 6, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-09

Locations

RU (21)