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

NCT03892707 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-10-06

Study results available
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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

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • Woerwag Pharma LLC

    lead INDUSTRY

Principal Investigators

  • Vladimir Parfenov · I.M. Sechenov First Moscow State Medical University

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2019-11-05
Completion
2019-11-05

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892707 on ClinicalTrials.gov