CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 500 enrolled
Drug / intervention
Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositumdrug
Likely dose
Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositum 2 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03892707
NCT03892707N/ACompleted
CompareCT.gov

Observational Study of Effectiveness and Safety of Add-on Milgamma® and Milgamma® Compositum Step-Therapy in Routine Practice of Management of Adult Patients With Acute Non-Specific Low Back Pain Receiving Modern NSAIDs

Woerwag Pharma LLC·observational·Posted Mar 27, 2019·Updated Oct 6, 2021

In Brief

An observational study evaluating Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositum for Acute Non-specific Low Back Pain. Completed, enrolled 500 participants across 21 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Non-specific Low Back Pain
CountriesRussia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 27, 2019
Enrollment StartDec 15, 2018
Primary CompletionNov 5, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.3 years ago

Interventions

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

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.