CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 805 enrolled
Drug / intervention
nicoboxil +3 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.

Search/NCT01708915
NCT01708915Phase 3Completed

A Multi-centre, Double-blind, Randomised, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Topically Applied Hyperemisation-inducing Ointment (2cm Ointment Line Per Application; up to 3 Times Daily for up to 4 Days) Containing 2.5% Nicoboxil/0.4% Nonivamide Versus 2.5% Nicoboxil, 0.4% Nonivamide and Placebo in Patients 18 to 65 Years of Age With Acute Low Back Pain

Boehringer Ingelheim·interventional·Posted Oct 17, 2012·Updated May 29, 2014

In Brief

A Phase 3 clinical trial evaluating nicoboxil, placebo matching nonivamide + nicoboxil, and 2 other interventions for Acute Low Back Pain. Completed, enrolled 805 participants across 37 sites.

Detailed Summary

The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of acute low back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2012
Enrollment StartOct 1, 2012
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.7 years ago

Interventions

nicoboxildrug

2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

placebo matching nonivamide + nicoboxildrug

2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

nonivamide + nicoboxil (Finalgon)drug

2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

nonivamidedrug

2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period