Trial Outcomes & Findings for Nonivamide/Nicoboxil Ointment in Acute Low Back Pain (NCT NCT01708915)

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 first ointment application. Means were adjusted for centre effect and baseline value.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

805 participants

Primary outcome timeframe

Baseline and 8 hours after first ointment application

Results posted on

2014-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Patients treated with placebo ointment	Nicoboxil Patients treated with ointments containing 2.5% nicoboxil alone	Nonivamide Patients treated with ointments containing 0.4% nonivamide alone	Nicoboxil/Nonivamide Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
Overall Study STARTED	204	201	198	202
Overall Study COMPLETED	118	139	152	169
Overall Study NOT COMPLETED	86	62	46	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients treated with placebo ointment	Nicoboxil Patients treated with ointments containing 2.5% nicoboxil alone	Nonivamide Patients treated with ointments containing 0.4% nonivamide alone	Nicoboxil/Nonivamide Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
Overall Study Adverse Event	1	0	9	13
Overall Study Lack of Efficacy	84	60	35	15
Overall Study Protocol Violation	0	0	0	1
Overall Study Withdrawal by Subject	0	1	2	2
Overall Study Other reasons than stated above	1	1	0	2

Baseline Characteristics

Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=204 Participants Patients treated with placebo ointment	Nicoboxil n=201 Participants Patients treated with ointments containing 2.5% nicoboxil alone	Nonivamide n=198 Participants Patients treated with ointments containing 0.4% nonivamide alone	Nicoboxil/Nonivamide n=202 Participants Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide	Total n=805 Participants Total of all reporting groups
Age, Continuous	39.2 years STANDARD_DEVIATION 13.27 • n=5 Participants	40.4 years STANDARD_DEVIATION 13.06 • n=7 Participants	42.2 years STANDARD_DEVIATION 13.53 • n=5 Participants	40.2 years STANDARD_DEVIATION 14.31 • n=4 Participants	40.5 years STANDARD_DEVIATION 13.57 • n=21 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	91 Participants n=7 Participants	103 Participants n=5 Participants	100 Participants n=4 Participants	388 Participants n=21 Participants
Sex: Female, Male Male	110 Participants n=5 Participants	110 Participants n=7 Participants	95 Participants n=5 Participants	102 Participants n=4 Participants	417 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 8 hours after first ointment application

Population: Patients from the Full Analysis Set (FAS): all randomised patients who used at least 1 dose of study medication and provided any post-treatment data for the pain intensity difference within 8 hours after first 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.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Patients treated with placebo ointment	Nicoboxil n=201 Participants Patients treated with ointments containing 2.5% nicoboxil alone	Nonivamide n=198 Participants Patients treated with ointments containing 0.4% nonivamide alone	Nicoboxil/Nonivamide n=202 Participants Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application	-1.049 units on a scale Standard Error 0.106	-1.428 units on a scale Standard Error 0.109	-2.252 units on a scale Standard Error 0.141	-2.410 units on a scale Standard Error 0.138

SECONDARY outcome

Timeframe: Baseline and 4 hours after first ointment application

Population: Patients from FAS.

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.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Patients treated with placebo ointment	Nicoboxil n=201 Participants Patients treated with ointments containing 2.5% nicoboxil alone	Nonivamide n=198 Participants Patients treated with ointments containing 0.4% nonivamide alone	Nicoboxil/Nonivamide n=202 Participants Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application	-0.650 units on a scale Standard Error 0.077	-0.968 units on a scale Standard Error 0.091	-1.641 units on a scale Standard Error 0.110	-1.699 units on a scale Standard Error 0.109

SECONDARY outcome

Timeframe: Baseline and 1 to 4 days

Population: Patients from FAS with evaluable data for the pain intensity at baseline and for the avarage pain intensity on the last individual treatment day.

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.

Outcome measures

Outcome measures
Measure	Placebo n=200 Participants Patients treated with placebo ointment	Nicoboxil n=200 Participants Patients treated with ointments containing 2.5% nicoboxil alone	Nonivamide n=198 Participants Patients treated with ointments containing 0.4% nonivamide alone	Nicoboxil/Nonivamide n=199 Participants Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day	-1.884 units on a scale Standard Error 0.160	-2.371 units on a scale Standard Error 0.160	-3.074 units on a scale Standard Error 0.161	-3.540 units on a scale Standard Error 0.159

SECONDARY outcome

Timeframe: 1 to 4 days

Population: Patients from FAS.

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

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Patients treated with placebo ointment	Nicoboxil n=201 Participants Patients treated with ointments containing 2.5% nicoboxil alone	Nonivamide n=198 Participants Patients treated with ointments containing 0.4% nonivamide alone	Nicoboxil/Nonivamide n=202 Participants Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
Patient Assessment of Efficacy on the Last Individual Treatment Day Very good	9 participants 0.160	19 participants 0.160	34 participants 0.161	50 participants 0.159
Patient Assessment of Efficacy on the Last Individual Treatment Day Good	47 participants	67 participants	85 participants	88 participants
Patient Assessment of Efficacy on the Last Individual Treatment Day Fair	22 participants	20 participants	27 participants	20 participants
Patient Assessment of Efficacy on the Last Individual Treatment Day Poor	125 participants	94 participants	52 participants	42 participants
Patient Assessment of Efficacy on the Last Individual Treatment Day Missing	1 participants	1 participants	0 participants	2 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicoboxil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nonivamide

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicoboxil/Nonivamide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=204 participants at risk Patients treated with placebo ointment	Nicoboxil n=201 participants at risk Patients treated with ointments containing 2.5% nicoboxil alone	Nonivamide n=198 participants at risk Patients treated with ointments containing 0.4% nonivamide alone	Nicoboxil/Nonivamide n=202 participants at risk Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide alone
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/204 • Up to 4 days	0.00% 0/201 • Up to 4 days	0.51% 1/198 • Up to 4 days	0.00% 0/202 • Up to 4 days

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER