NCT01708915

Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 805 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Low Back Pain

Interventions

Type	Name	Description
DRUG	nicoboxil	2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
DRUG	placebo matching nonivamide + nicoboxil	2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
DRUG	nonivamide + nicoboxil (Finalgon)	2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
DRUG	nonivamide	2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-10-17
• Last updated: 2014-05-29
• Results posted: 2014-05-15

Locations

37 sites across 1 country: Germany