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

NCT02300311 | Completed Phase 3 Results

• 1 other identifier: 69.53
• Study Type: interventional
• Target: 138
• Locations: 2 countries
• Sites: 8

Brief Summary

To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in patients with acute low back pain. To investigate the safety and tolerability of repeated use of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)

  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.

  Baseline and 8 hours after trial medication application

Secondary Outcomes (3)

• Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)

  Baseline and 4 hours after trial medication application

• Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day

  Baseline and 1 to 4 days

• Patient's Assessment of the Efficacy on the Last Individual Treatment Day

  1 to 4 days

Study Arms (2)

nonivamide + nicoboxil (Finalgon cream)

EXPERIMENTAL

2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

Drug: nonivamide + nicoboxil (Finalgon cream)

placebo

PLACEBO COMPARATOR

2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

Drug: placebo matching nonivamide + nicoboxil (Finalgon cream)

Interventions

nonivamide + nicoboxil (Finalgon cream) DRUG

2 cm cream line for a skin area approximately 20 x 20 cm2 up to 3 times in a 24 hour period

nonivamide + nicoboxil (Finalgon cream)

placebo matching nonivamide + nicoboxil (Finalgon cream) DRUG

2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and local regulation prior to participation in the trial.
• Patients must agree to cooperate with all trial evaluations and perform all required tasks.
• Patients must have acute nonspecific low back pain, ICD-10 code: M54.5.
• Patients must have acute low back pain for more than 2 days and less than 21 days (= 3 weeks).
• Male or female more or equal 18 and less or equal 65 years of age at Visit 1(Baseline).
• Low back pain Pain intensity more or equal 5 on a 0-10 numerical rating scale (NRS).

You may not qualify if:

• Patients with a significant disease other than acute nonspecific low back pain. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
• Multilocular pain or panalgesia.
• History of more than 3 low back pain episodes in the last 6 months.
• Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), traumatic, or infective origins.
• Abnormal findings in at least one of the following assessments: Achilles tendon reflex, patella reflex, heel walking, toe walking, cutaneous sensitivity of the legs (including gluteal region), paresis tests in supine position upon dorsiflexion, plantarflexion, hip flexion, knee extension.
• Neurogenic Bladder and/or rectum dysfunction.
• Any condition, disease or concomitant treatment that in the judgement of the investigator will affect the patient's ability to participate in the clinical trial or which will influence the trial methodology used.
• Negative experience in the past with heat treatment for muscle complaints (e. g. hot water bottle, heat pads, hyperemisation-inducing topical creams, ointments or patches).
• Patients with history of treatment of back pain with centrally acting drugs (e.g. opioids) and muscle relaxants within 6 months prior to enrolment.
• Surgery due to back pain or rehabilitation due to back pain in the last 12 months.
• Spinal injection back pain treatment within 6 months prior to enrolment.
• Intake of antidepressant/antipsychotic medication within 4 weeks prior to enrolment.
• Treatment of the recent low back pain period with oral analgesics for more than 4 consecutive days.
• Locally applied medication to the back within 24 hours prior to enrolment (topical treatments, injections).
• Non-pharmacological low back pain treatment (physiotherapy, heat treatment \[e.g. hot water bottle, heat patch\], or massages) within 12 hours prior to enrolment.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (8)

69.53.53201 Boehringer Ingelheim Investigational Site

Kyiv, Russia

Location

69.53.53102 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

69.53.53103 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

69.53.53105 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

69.53.53106 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

69.53.53107 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

69.53.53202 Boehringer Ingelheim Investigational Site

Kyiv, Ukraine

Location

69.53.53203 Boehringer Ingelheim Investigational Site

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

nonivamide; nicoboxil

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 25, 2014
• Study Start: January 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 13, 2016
• Results First Posted: September 13, 2016

Record last verified: 2016-07

Locations

RU (6); UA (2)