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

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ClinicalTrials.gov Identifier: NCT02300311
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Drug: nonivamide + nicoboxil (Finalgon cream)
Drug: placebo matching nonivamide + nicoboxil (Finalgon cream)
Enrollment 138
Recruitment Details  
Pre-assignment Details Multinational, multi-centre, randomised, double-blind, placebo-controlled, parallel group, 2-arm study with a treatment duration of up to 4 days
Arm/Group Title Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Hide Arm/Group Description Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.

Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.

Treatment duration consists of up to 4 days.

Period Title: Overall Study
Started 69 69
Completed 50 69
Not Completed 19 0
Reason Not Completed
Other than the reason specified             1             0
Refused to continue taking medication             18             0
Arm/Group Title Placebo Finalgon® Cream (Nicoboxil/ Nonivamide) Total
Hide Arm/Group Description Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.

Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.

Treatment duration consists of up to 4 days.

Total of all reporting groups
Overall Number of Baseline Participants 69 69 138
Hide Baseline Analysis Population Description
Treated set (TS): All randomised patients who used at least one dose of study medication were included in the treated set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 69 participants 138 participants
42.52  (11.34) 44.25  (12.68) 43.38  (12.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 69 participants 138 participants
Female
37
  53.6%
49
  71.0%
86
  62.3%
Male
32
  46.4%
20
  29.0%
52
  37.7%
1.Primary Outcome
Title Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)
Hide Description

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.

Time Frame Baseline and 8 hours after trial medication application
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.
Arm/Group Title Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Hide Arm/Group Description:
Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.

Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.

Treatment duration consists of up to 4 days.

Overall Number of Participants Analyzed 69 69
Mean (Standard Error)
Unit of Measure: points on a scale
-0.98  (0.215) -2.82  (0.221)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Finalgon® Cream (Nicoboxil/ Nonivamide)
Comments

PID8 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 8 hours.

The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, 4, 6 and 8 hours.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.
Method REML based repeated measures approach
Comments restricted maximum likelihood (REML) based repeated measures approach
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.849
Confidence Interval (2-Sided) 95%
-2.454 to -1.244
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.306
Estimation Comments Differences between the treatment group effects (Finalgon® cream – placebo).
2.Secondary Outcome
Title Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)
Hide Description 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.
Time Frame Baseline and 4 hours after trial medication application
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.
Arm/Group Title Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Hide Arm/Group Description:
Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.

Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.

Treatment duration consists of up to 4 days.

Overall Number of Participants Analyzed 69 69
Mean (Standard Error)
Unit of Measure: points on a scale
-0.77  (0.157) -2.11  (0.196)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Finalgon® Cream (Nicoboxil/ Nonivamide)
Comments

PID4 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 4 hours.

The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, and 4 hours.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.
Method REML based repeated measures approach
Comments restricted maximum likelihood (REML) based repeated measures approach
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.341
Confidence Interval (2-Sided) 95%
-1.832 to -0.851
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.248
Estimation Comments Differences between the treatment group effects (Finalgon® cream – placebo)
3.Secondary Outcome
Title Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day
Hide Description

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.

Time Frame Baseline and 1 to 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.
Arm/Group Title Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Hide Arm/Group Description:
Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.

Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.

Treatment duration consists of up to 4 days.

Overall Number of Participants Analyzed 69 69
Mean (Standard Error)
Unit of Measure: points on a scale
-2.17  (0.272) -5.13  (0.279)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Finalgon® Cream (Nicoboxil/ Nonivamide)
Comments The difference of average pain intensity from pre-dose baseline on the last individual treatment day was analysed using ANCOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA using the fixed, categorical effects of treatment and country as well as the continuous covariate of baseline PI.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.958
Confidence Interval (2-Sided) 95%
-3.712 to -2.205
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.381
Estimation Comments Differences between the treatment group effects (Finalgon® cream – placebo)
4.Secondary Outcome
Title Patient's Assessment of the Efficacy on the Last Individual Treatment Day
Hide Description 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).
Time Frame 1 to 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.
Arm/Group Title Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Hide Arm/Group Description:
Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.

Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.

Treatment duration consists of up to 4 days.

Overall Number of Participants Analyzed 69 69
Measure Type: Number
Unit of Measure: percentage of participants
Very good 13.0 29.0
Good 17.4 58.0
Fair 20.3 13.0
Poor 47.8 0.0
Missing 1.4 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Finalgon® Cream (Nicoboxil/ Nonivamide)
Comments

For the analysis of the repeated multinomial efficacy endpoint ‘patient assessment of efficacy’ on the last individual treatment day, ordinal logistic regression models is used.

Only non−missing data is analysed in the statistical model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Ordinal logistic regression models adjusting for the continuous covariate ‘baseline PI’ and the categorical variable ‘country’ was performed.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.370
Confidence Interval (2-Sided) 95%
5.342 to 24.199
Estimation Comments Odds ratio of (Finalgon® cream / placebo)
Time Frame Adverse Event's collected after the first dose and upto the residual effect period (REP) period after the last drug administration (from first study administration until 24 hours after last study administration) ie. up to 5 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Hide Arm/Group Description Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days. Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
All-Cause Mortality
Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)   0/69 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Finalgon® Cream (Nicoboxil/ Nonivamide)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)   0/69 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 800-243-0127 ext +1
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02300311     History of Changes
Other Study ID Numbers: 69.53
First Submitted: November 24, 2014
First Posted: November 25, 2014
Results First Submitted: May 24, 2016
Results First Posted: September 13, 2016
Last Update Posted: September 13, 2016