Low Back PainPhase 3NCT02300311

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

A Phase 3 study testing nonivamide + nicoboxil (Finalgon cream) in people with Low Back Pain, run by Boehringer Ingelheim at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Low Back Pain
What is being tested?: nonivamide + nicoboxil (Finalgon cream)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 138 participants
Where: 8 sitesin 2 countries
Study dates: Jan 2015to May 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 33Show fewer

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.
Administration of other analgesics within 12 h prior to enrolment (exception: acetylsalicylic acid [ASS] up to 100 mg/daily for anti-platelet-aggregation therapy).
Non-pharmacological low back pain treatment (physiotherapy, heat treatment [e.g. hot water bottle, heat patch], or massages) within 12 hours prior to enrolment.
Participation in an investigational drug or device trial within 4 weeks prior to enrolment.
History of treatment of back pain with centrally acting drugs (e.g. opioids) and muscle relaxants.
Treatment of the recent low back pain period with oral analgesics for more than 4 consecutive days.
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.
Known hypersensitivity to nicoboxil, nonivamide, or other ingredients of the cream.
Known hypersensitivity to paracetamol.
Skin lesions (e.g. rash, bruising, laceration) in the back region.
Known history of central nervous system diseases with severe intellectual and memory disorders, psychiatric disorders.
History of abuse of alcohol/drugs within six months prior to enrolment.
Acute and relapsed chronic kidney diseases.
Severe hepatocellular insufficiency.
Pregnant or nursing women, including female patients with positive ß-HCG test at Visit 1.
Female patients of child-bearing potential not using highly effective method of birth control.
Patients who are currently participating in another trial or who have been participating in another trial within one month prior to Visit 1, and patients who have previously been randomised in this trial.

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

Russia6 sites

69.53.53201 Boehringer Ingelheim Investigational Site
Kyiv
69.53.53102 Boehringer Ingelheim Investigational Site
Saint Petersburg
69.53.53103 Boehringer Ingelheim Investigational Site
Saint Petersburg
69.53.53105 Boehringer Ingelheim Investigational Site
Saint Petersburg
69.53.53106 Boehringer Ingelheim Investigational Site
Saint Petersburg
69.53.53107 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Ukraine2 sites

69.53.53202 Boehringer Ingelheim Investigational Site
Kyiv
69.53.53203 Boehringer Ingelheim Investigational Site
Kyiv

Other trials in Ukraine

About this study

Official title: A Multinational, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Finalgon® Cream (1.08% Nicoboxil/ 0.17% Nonivamide) in the Treatment of Acute Low Back Pain

Conditions: Low Back Pain
Being tested: nonivamide + nicoboxil (Finalgon cream), placebo matching nonivamide + nicoboxil (Finalgon cream)
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
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

Study groups in NCT02300311
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: placebo matching nonivamide + nicoboxil (Finalgon cream)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: Baseline and 4 hours after trial medication application
Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day
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.
Measured: Baseline and 1 to 4 days
Patient's Assessment of the Efficacy on the Last Individual Treatment Day
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).
Measured: 1 to 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015May 2015

First posted25 Nov 2014 (estimated)
Study startJan 2015
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02300311
Sponsor's protocol ID: 69.53
Status last verified: Jul 2016
First submitted: 24 Nov 2014
Last updated: 13 Sep 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multinational, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Finalgon® Cream (1.08% Nicoboxil/ 0.17% Nonivamide) in the Treatment of Acute Low Back Pain
ClinicalTrials.gov ID: NCT02300311
Acronym / sponsor ID: 69.53
Conditions: Low Back Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 25 Nov 2014 (estimated)
Results: Posted 13 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
nonivamide + nicoboxil (Finalgon cream)	Experimental	Drug: nonivamide + nicoboxil (Finalgon cream)2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period
placebo	Placebo comparator	Drug: placebo matching nonivamide + nicoboxil (Finalgon cream)2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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).

Key exclusion criteria (33 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nonivamide + nicoboxil (Finalgon cream)2 cm cream line for a skin area approximately 20 x 20 cm2 up to 3 times in a 24 hour period	Drug	nonivamide + nicoboxil (Finalgon cream)
placebo matching nonivamide + nicoboxil (Finalgon cream)2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period	Drug	placebo

Primary outcome

Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)
Time frame: Baseline and 8 hours after trial medication 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 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.

3 secondary outcomes

Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)
Time frame: Baseline and 4 hours after trial medication application
Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day
Time frame: Baseline and 1 to 4 days
Patient's Assessment of the Efficacy on the Last Individual Treatment Day
Time frame: 1 to 4 days

Results and safety

Results posted to the registry on 13 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	69	50
Finalgon® Cream (Nicoboxil/ Nonivamide)	69	69

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

Time frame: Baseline and 8 hours after trial medication application. Mean (Standard Error). Unit: points on a scale

Measure	Placebo n = 69	Finalgon® Cream (Nicoboxil/ Nonivamide) n = 69
Value	-0.98 (0.215)	-2.82 (0.221)

Placebo vs Finalgon® Cream (Nicoboxil/ Nonivamide): Mean Difference (Final Values): -1.849 (95% CI -2.454 to -1.244), p <0.0001, REML based repeated measures approach

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 69 (0%)	0 of 69 (0%)	Not reported
Finalgon® Cream (Nicoboxil/ Nonivamide)	0 of 69 (0%)	0 of 69 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nonivamide + nicoboxil (Finalgon cream) in people with Low Back Pain, run by Boehringer Ingelheim at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Russia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h) (time frame: Baseline and 8 hours after trial medication application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02300311.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.