At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 138 enrolled
Drug / intervention
nonivamide + nicoboxil (Finalgon cream) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multinational, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Finalgon® Cream (1.08% Nicoboxil/ 0.17% Nonivamide) in the Treatment of Acute Low Back Pain
In Brief
A Phase 3 clinical trial evaluating nonivamide + nicoboxil (Finalgon cream) and placebo matching nonivamide + nicoboxil (Finalgon cream) for Low Back Pain. Completed, enrolled 138 participants across 8 sites in 2 countries.
Detailed Summary
To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in patients with acute low back pain. To investigate the safety and tolerability of repeated use of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesRussia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartJan 2015
Primary CompletionMay 2015
TodayJul 2026
First PostedNov 25, 2014
Enrollment StartJan 1, 2015
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.6 years ago
Interventions
nonivamide + nicoboxil (Finalgon cream)drug
2 cm cream line for a skin area approximately 20 x 20 cm2 up to 3 times in a 24 hour period
placebo matching nonivamide + nicoboxil (Finalgon cream)drug
2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period