Trial Outcomes & Findings for Efficacy and Safety of Finalgon® Cream Multiple Doses in Acute Low Back Pain (NCT NCT02300311)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

138 participants

Primary outcome timeframe

Baseline and 8 hours after trial medication application

Results posted on

2016-09-13

Participant Flow

Multinational, multi-centre, randomised, double-blind, placebo-controlled, parallel group, 2-arm study with a treatment duration of up to 4 days

Participant milestones

Participant milestones
Measure	Placebo 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.	Finalgon® Cream (Nicoboxil/ Nonivamide) 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 Study STARTED	69	69
Overall Study COMPLETED	50	69
Overall Study NOT COMPLETED	19	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 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.	Finalgon® Cream (Nicoboxil/ Nonivamide) 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 Study Other than the reason specified	1	0
Overall Study Refused to continue taking medication	18	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=69 Participants 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.	Finalgon® Cream (Nicoboxil/ Nonivamide) n=69 Participants 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 n=138 Participants Total of all reporting groups
Age, Continuous	42.52 years STANDARD_DEVIATION 11.34 • n=5 Participants	44.25 years STANDARD_DEVIATION 12.68 • n=7 Participants	43.38 years STANDARD_DEVIATION 12.02 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	49 Participants n=7 Participants	86 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	20 Participants n=7 Participants	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 hours after trial medication application

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants 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.	Finalgon® Cream (Nicoboxil/ Nonivamide) n=69 Participants 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.
Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)	-0.98 points on a scale Standard Error 0.215	-2.82 points on a scale Standard Error 0.221

SECONDARY outcome

Timeframe: Baseline and 4 hours after trial medication application

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants 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.	Finalgon® Cream (Nicoboxil/ Nonivamide) n=69 Participants 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.
Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)	-0.77 points on a scale Standard Error 0.157	-2.11 points on a scale Standard Error 0.196

SECONDARY outcome

Timeframe: Baseline and 1 to 4 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants 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.	Finalgon® Cream (Nicoboxil/ Nonivamide) n=69 Participants 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.
Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day	-2.17 points on a scale Standard Error 0.272	-5.13 points on a scale Standard Error 0.279

SECONDARY outcome

Timeframe: 1 to 4 days

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants 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.	Finalgon® Cream (Nicoboxil/ Nonivamide) n=69 Participants 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.
Patient's Assessment of the Efficacy on the Last Individual Treatment Day Very good	13.0 percentage of participants 0.272	29.0 percentage of participants 0.279
Patient's Assessment of the Efficacy on the Last Individual Treatment Day Good	17.4 percentage of participants	58.0 percentage of participants
Patient's Assessment of the Efficacy on the Last Individual Treatment Day Fair	20.3 percentage of participants	13.0 percentage of participants
Patient's Assessment of the Efficacy on the Last Individual Treatment Day Poor	47.8 percentage of participants	0.0 percentage of participants
Patient's Assessment of the Efficacy on the Last Individual Treatment Day Missing	1.4 percentage of participants	0.0 percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Finalgon® Cream (Nicoboxil/ Nonivamide)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER