Nonivamide/Nicoboxil Ointment in Acute Low Back Pain
- Conditions
- Acute Low Back Pain
- Interventions
- Drug: nonivamide + nicoboxil (Finalgon)Drug: nonivamideDrug: nicoboxilDrug: 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 805
Not provided
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)
69.52.49032 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
69.52.49024 Boehringer Ingelheim Investigational Site
🇩🇪Essen, Germany
69.52.49039 Boehringer Ingelheim Investigational Site
🇩🇪Fürth, Germany
69.52.49004 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
69.52.49026 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
69.52.49041 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
69.52.49007 Boehringer Ingelheim Investigational Site
🇩🇪Bad Lippspringe, Germany
69.52.49002 Boehringer Ingelheim Investigational Site
🇩🇪Einbeck, Germany
69.52.49031 Boehringer Ingelheim Investigational Site
🇩🇪Essen, Germany
69.52.49015 Boehringer Ingelheim Investigational Site
🇩🇪Kaarst, Germany
69.52.49003 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
69.52.49014 Boehringer Ingelheim Investigational Site
🇩🇪Künzing, Germany
69.52.49011 Boehringer Ingelheim Investigational Site
🇩🇪Weilburg, Germany
69.52.49033 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
69.52.49018 Boehringer Ingelheim Investigational Site
🇩🇪Goch, Germany
69.52.49023 Boehringer Ingelheim Investigational Site
🇩🇪Wangen, Germany
69.52.49028 Boehringer Ingelheim Investigational Site
🇩🇪Meßkirch, Germany
69.52.49005 Boehringer Ingelheim Investigational Site
🇩🇪Everswinkel, Germany
69.52.49042 Boehringer Ingelheim Investigational Site
🇩🇪Karlsruhe-Rüppurr, Germany
69.52.49027 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
69.52.49019 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
69.52.49022 Boehringer Ingelheim Investigational Site
🇩🇪Haag, Germany
69.52.49036 Boehringer Ingelheim Investigational Site
🇩🇪Essen, Germany
69.52.49035 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
69.52.49040 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
69.52.49012 Boehringer Ingelheim Investigational Site
🇩🇪Neunkirchen, Germany
69.52.49020 Boehringer Ingelheim Investigational Site
🇩🇪Rodgau, Germany
69.52.49037 Boehringer Ingelheim Investigational Site
🇩🇪Siegen, Germany
69.52.49016 Boehringer Ingelheim Investigational Site
🇩🇪Stockach, Germany
69.52.49025 Boehringer Ingelheim Investigational Site
🇩🇪Großheirath-Rossach, Germany
69.52.49009 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
69.52.49034 Boehringer Ingelheim Investigational Site
🇩🇪Ludwigshafen, Germany
69.52.49013 Boehringer Ingelheim Investigational Site
🇩🇪Köthen, Germany
69.52.49030 Boehringer Ingelheim Investigational Site
🇩🇪Meßkirch, Germany
69.52.49010 Boehringer Ingelheim Investigational Site
🇩🇪Straßkirchen, Germany
69.52.49021 Boehringer Ingelheim Investigational Site
🇩🇪Villingen-Schwenningen, Germany
69.52.49029 Boehringer Ingelheim Investigational Site
🇩🇪Münster, Germany