Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

Phase 3

Completed

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

• Registration Number: NCT01708915
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-04-17
• Results First Submitted QC: 2014-04-17
• Status Verified: 2014-05
• Results First Posted: 2014-05-15
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 805

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application	Baseline and 8 hours after first ointment 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 first ointment application. Means were adjusted for centre effect and baseline value.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application	Baseline and 4 hours after first ointment 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 first ointment application. Means were adjusted for centre effect and baseline value.
Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day	Baseline and 1 to 4 days	Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.
Patient Assessment of Efficacy on the Last Individual Treatment Day	1 to 4 days	Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application

Trial Locations

Locations (37)

69.52.49007 Boehringer Ingelheim Investigational Site; 🇩🇪 Bad Lippspringe, Germany

69.52.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

69.52.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

69.52.49026 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

69.52.49032 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

69.52.49033 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

69.52.49041 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

69.52.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Einbeck, Germany

69.52.49024 Boehringer Ingelheim Investigational Site; 🇩🇪 Essen, Germany

69.52.49031 Boehringer Ingelheim Investigational Site; 🇩🇪 Essen, Germany

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