Efficacy and Safety of Finalgon® Cream Multiple Doses in Acute Low Back Pain

Phase 3

Completed

• Conditions: Low Back Pain
• Interventions: Drug: placebo matching nonivamide + nicoboxil (Finalgon cream); Drug: nonivamide + nicoboxil (Finalgon cream)

• Registration Number: NCT02300311
• Lead Sponsor: Boehringer Ingelheim

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Study Start: 2015-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-05-24
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Results First Posted: 2016-09-13
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo matching nonivamide + nicoboxil (Finalgon cream)	2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period
nonivamide + nicoboxil (Finalgon cream)	nonivamide + nicoboxil (Finalgon cream)	2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

Primary Outcome Measures

Name	Time	Method
Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)	Baseline and 8 hours after trial medication application	Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after trial medication application.; The left side of each scale (0) is marked 'no pain' and the right side of the scale (10) is marked 'worst pain possible'.; PID8h= Pain intensity (PI)8h - PI(baseline).; Means reported are the adjusted means.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)	Baseline and 4 hours after trial medication application	Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after trial medication application. The left side of each scale (0) is marked 'no pain' and the right side of the scale (10) is marked 'worst pain possible'. PID4h= PI(4h) - PI(baseline). Means reported are the adjusted means.
Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day	Baseline and 1 to 4 days	Difference of average pain intensity from pre-dose baseline on the last individual treatment day (The last individual treatment day was the last day on which the patient had recorded the study drug applications within the patient diary). Pain intensity was assessed by the patient using 0-10 numerical rating scale (NRS).; Patients were given two 0-10 numerical rating scales (NRS) - to self-report of pain intensity at given time points for the period 0-8 hours post first dose and to self-report of average pain intensity they had at each treatment day. The left side of each scale (0) is marked 'no pain' and the right side of the scale (10) is marked 'worst pain possible'. APIDtime point = APItime point - PI baseline (time point is the last individual treatment day (either Day 1, 2, 3 or 4 after drug administration)).; Means reported are the adjusted means.
Patient's Assessment of the Efficacy on the Last Individual Treatment Day	1 to 4 days	Patients were asked to rate the effect of the study medication for relieving their low back pain using a 4-point verbal rating scale (1=Poor, 2= Fair, 3=Good, 4=Very Good).

Trial Locations

Locations (8)

69.53.53202 Boehringer Ingelheim Investigational Site; 🇺🇦 Kyiv, Ukraine

69.53.53203 Boehringer Ingelheim Investigational Site; 🇺🇦 Kyiv, Ukraine

69.53.53103 Boehringer Ingelheim Investigational Site; 🇷🇺 St. Petersburg, Russian Federation

69.53.53201 Boehringer Ingelheim Investigational Site; 🇷🇺 Kyiv, Russian Federation

69.53.53102 Boehringer Ingelheim Investigational Site; 🇷🇺 St. Petersburg, Russian Federation

69.53.53105 Boehringer Ingelheim Investigational Site; 🇷🇺 St. Petersburg, Russian Federation

69.53.53106 Boehringer Ingelheim Investigational Site; 🇷🇺 St. Petersburg, Russian Federation

69.53.53107 Boehringer Ingelheim Investigational Site; 🇷🇺 St. Petersburg, Russian Federation