Acute Low Back PainPhase 3NCT01708915

Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

A Phase 3 study testing nicoboxil, nonivamide + nicoboxil (Finalgon) and nonivamide in people with Acute Low Back Pain, run by Boehringer Ingelheim at 37 sites in Germany.

Completed

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

Official record

Search all trials

Trial summary

The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of acute low back pain. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Acute Low Back Pain
What is being tested?: nicoboxil, nonivamide + nicoboxil (Finalgon) and nonivamide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 805 participants
Where: 37 sitesGermany
Study dates: Oct 2012to Apr 2013
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 Hermonisation (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.
Acute low back pain for more than 2 days and less than 21 days (= 3 weeks)
Male or female patients aged 18 to 65 years
Low back pain rating >5 on a 0-10 numerical rating scale (NRS).
Female patients of childbearing potential may participate only in case of availability of a negative urine pregnancy test and a confirmed menstrual period prior to study entry and using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, appropriate intrauterine devices, sexual abstinence or vasectomised partner. Barrier methods of contraception (e.g. condom, diaphragma or occlusive cap) are accepted if used in combination with spermicides (e.g. foam, gel). Female patients will be considered being of childbearing potential unless surgically sterilised by bilateral tubal ligation/salpingectomy or hysterectomy or post-menopausal for at least one year.

Who cannot join

Multilocular pain or panalgesia
History of more than three low back pain episodes in the last six months
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
Bladder and/or rectum dysfunction
Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), traumatic, or infective origins
Any condition, disease or concomitant treatment that in the judgement of the Investigator will affect the subject's ability to participate in the clinical trial or which will influence the test methodology used

Show all 22Show fewer

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)
History of treatment of back pain with centrally acting analgesics (e. g. opioids) and muscle relaxants
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 enrollment
Intake of antidepressant/antipsychotic medication within 4 weeks prior to enrollment
Treatment of the recent low back pain period with oral analgesics for more than 4 consecutive days
Locally applied medication to the back within 48 hours prior to enrollment (topical treatments, injections)
Administration of other analgesics within 24 h prior to enrollment (exception: acetyl salicylic 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 h prior to enrollment
Participation in an investigational drug or device trial within 4 weeks prior to enrollment
Hypersensitivity to Nicoboxil, Nonivamide, or paracetamol
Known hypersensitivity to any other ingredient, especially to sorbic acid/sorbate, to citronella oil containing e.g. the fragrance compounds geraniol, citronellol and citronellal, or to relevant flowers containing these compounds such as geranium, lavender, jasmine or rose. For patients with known hypersensitivity to perfumes or known type IV hypersensitivity to fragrance-mix I, the application of the investigational product should be performed only with particular caution.
Skin lesions (e. g., rash, dermatitis, bruising, laceration) in the back region
Drug dependence and/or alcohol abuse
Severe hepatocellular insufficiency
Patients who are pregnant or breast-feeding

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

Germany37 sites

69.52.49007 Boehringer Ingelheim Investigational Site
Bad Lippspringe
69.52.49003 Boehringer Ingelheim Investigational Site
Berlin
69.52.49004 Boehringer Ingelheim Investigational Site
Berlin
69.52.49026 Boehringer Ingelheim Investigational Site
Berlin
69.52.49032 Boehringer Ingelheim Investigational Site
Berlin
69.52.49033 Boehringer Ingelheim Investigational Site
Berlin
69.52.49041 Boehringer Ingelheim Investigational Site
Berlin
69.52.49027 Boehringer Ingelheim Investigational Site
Cologne
69.52.49035 Boehringer Ingelheim Investigational Site
Cologne
69.52.49040 Boehringer Ingelheim Investigational Site
Cologne
69.52.49002 Boehringer Ingelheim Investigational Site
Einbeck
69.52.49024 Boehringer Ingelheim Investigational Site
Essen
69.52.49031 Boehringer Ingelheim Investigational Site
Essen
69.52.49036 Boehringer Ingelheim Investigational Site
Essen
69.52.49005 Boehringer Ingelheim Investigational Site
Everswinkel
69.52.49039 Boehringer Ingelheim Investigational Site
Fürth
69.52.49018 Boehringer Ingelheim Investigational Site
Goch
69.52.49025 Boehringer Ingelheim Investigational Site
Großheirath-Rossach
69.52.49022 Boehringer Ingelheim Investigational Site
Haag
69.52.49009 Boehringer Ingelheim Investigational Site
Hamburg
69.52.49019 Boehringer Ingelheim Investigational Site
Hamburg
69.52.49015 Boehringer Ingelheim Investigational Site
Kaarst
69.52.49042 Boehringer Ingelheim Investigational Site
Karlsruhe-Rüppurr
69.52.49013 Boehringer Ingelheim Investigational Site
Köthen
69.52.49014 Boehringer Ingelheim Investigational Site
Künzing
69.52.49034 Boehringer Ingelheim Investigational Site
Ludwigshafen
69.52.49028 Boehringer Ingelheim Investigational Site
Messkirch
69.52.49030 Boehringer Ingelheim Investigational Site
Messkirch
69.52.49029 Boehringer Ingelheim Investigational Site
Münster
69.52.49012 Boehringer Ingelheim Investigational Site
Neunkirchen
69.52.49020 Boehringer Ingelheim Investigational Site
Rodgau
69.52.49037 Boehringer Ingelheim Investigational Site
Siegen
69.52.49016 Boehringer Ingelheim Investigational Site
Stockach
69.52.49010 Boehringer Ingelheim Investigational Site
Straßkirchen
69.52.49021 Boehringer Ingelheim Investigational Site
Villingen-Schwenningen
69.52.49023 Boehringer Ingelheim Investigational Site
Wangen
69.52.49011 Boehringer Ingelheim Investigational Site
Weilburg

Other trials in Germany

About this study

Official title: A Multi-centre, Double-blind, Randomised, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Topically Applied Hyperemisation-inducing Ointment (2cm Ointment Line Per Application; up to 3 Times Daily for up to 4 Days) Containing 2.5% Nicoboxil/0.4% Nonivamide Versus 2.5% Nicoboxil, 0.4% Nonivamide and Placebo in Patients 18 to 65 Years of Age With Acute Low Back Pain

Conditions: Acute Low Back Pain
Being tested: nicoboxil, placebo matching nonivamide + nicoboxil, nonivamide + nicoboxil (Finalgon), nonivamide

What participants receive

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

nicoboxilDrug
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
placebo matching nonivamide + nicoboxilDrug
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
nonivamide + nicoboxil (Finalgon)Drug
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
nonivamideDrug
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

Study groups in NCT01708915
Study group	Role	What they receive
nonivamide + nicoboxil (Finalgon)	Active comparator	2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period Receives: Drug: nonivamide + nicoboxil (Finalgon)
nonivamide	Active comparator	2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period Receives: Drug: nonivamide
nicoboxil	Active comparator	2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period Receives: Drug: nicoboxil
placebo	Placebo comparator	2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period Receives: Drug: placebo matching nonivamide + nicoboxil

What is being measured

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

Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours 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.
Measured: Baseline and 8 hours after first ointment application

Secondary outcomes (3)

Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application
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.
Measured: Baseline and 4 hours after first ointment application
Difference Between Baseline Pain Intensity and Average 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.
Measured: Baseline and 1 to 4 days
Patient Assessment of Efficacy on the Last Individual Treatment Day
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
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.

Oct 2012Apr 2013

First posted17 Oct 2012 (estimated)
Study startOct 2012
Primary completionApr 2013
Study completionApr 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute 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: 805 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01708915
Sponsor's protocol ID: 69.52
Other IDs: 2011-003890-27
Status last verified: May 2014
First submitted: 16 Oct 2012
Last updated: 29 May 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Gaubitz M, Schiffer T, Holm C, Richter E, Pisternick-Ruf W, Weiser T. Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of acute pain in the low back - A randomized, controlled trial. Eur J Pain. 2016 Feb;20(2):263-73. doi: 10.1002/ejp.719. Epub 2015 Apr 30.
PubMed 25929250

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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Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application
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Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
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Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
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All Acute Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Double-blind, Randomised, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Topically Applied Hyperemisation-inducing Ointment (2cm Ointment Line Per Application; up to 3 Times Daily for up to 4 Days) Containing 2.5% Nicoboxil/0.4% Nonivamide Versus 2.5% Nicoboxil, 0.4% Nonivamide and Placebo in Patients 18 to 65 Years of Age With Acute Low Back Pain
ClinicalTrials.gov ID: NCT01708915
Acronym / sponsor ID: 69.52
Conditions: Acute Low Back Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 805 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 17 Oct 2012 (estimated)
Results: Posted 15 May 2014

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: 4

Arm	Type	Receives
nonivamide + nicoboxil (Finalgon)	Active comparator	Drug: nonivamide + nicoboxil (Finalgon)2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
nonivamide	Active comparator	Drug: nonivamide2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
nicoboxil	Active comparator	Drug: nicoboxil2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
placebo	Placebo comparator	Drug: placebo matching nonivamide + nicoboxil2cm ointment line for a skin area of approximately 20 cm x 20 cm 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 Hermonisation (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.
Acute low back pain for more than 2 days and less than 21 days (= 3 weeks)
Male or female patients aged 18 to 65 years
Low back pain rating >5 on a 0-10 numerical rating scale (NRS).

Key exclusion criteria (22 listed)

Multilocular pain or panalgesia
History of more than three low back pain episodes in the last six months
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
Bladder and/or rectum dysfunction
Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), traumatic, or infective origins

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
nicoboxil2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period	Drug	nicoboxil
placebo matching nonivamide + nicoboxil2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period	Drug	placebo
nonivamide + nicoboxil (Finalgon)2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period	Drug	nonivamide + nicoboxil (Finalgon)
nonivamide2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period	Drug	nonivamide

Primary outcome

Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application
Time frame: Baseline and 8 hours after first ointment 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.

3 secondary outcomes

Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application
Time frame: Baseline and 4 hours after first ointment application
Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day
Time frame: Baseline and 1 to 4 days
Patient Assessment of Efficacy on the Last Individual Treatment Day
Time frame: 1 to 4 days

Results and safety

Results posted to the registry on 15 May 2014, 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	204	118
Nicoboxil	201	139
Nonivamide	198	152
Nicoboxil/Nonivamide	202	169

Primary outcome: Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application

Time frame: Baseline and 8 hours after first ointment application. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 204	Nicoboxil n = 201	Nonivamide n = 198	Nicoboxil/Nonivamide n = 202
Value	-1.049 (0.106)	-1.428 (0.109)	-2.252 (0.141)	-2.410 (0.138)

Placebo vs Nicoboxil/Nonivamide: Mean Difference (Final Values): -1.362 (95% CI -1.699 to -1.025), p <0.0001, Restricted Maximum Likelihood (REML)
Nicoboxil vs Nicoboxil/Nonivamide: Mean Difference (Final Values): -0.983 (95% CI -1.324 to -0.642), p <0.0001, Restricted Maximum Likelihood (REML)
Nonivamide vs Nicoboxil/Nonivamide: Mean Difference (Final Values): -0.158 (95% CI -0.541 to 0.225), p = 0.4171, Restricted Maximum Likelihood (REML)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 204 (0%)	0 of 204 (0%)	Not reported
Nicoboxil	0 of 201 (0%)	0 of 201 (0%)	Not reported
Nonivamide	1 of 198 (0.5%)	0 of 198 (0%)	Not reported
Nicoboxil/Nonivamide	0 of 202 (0%)	0 of 202 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25929250Gaubitz M, Schiffer T, Holm C, Richter E, Pisternick-Ruf W, Weiser T. Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of acute pain in the low back - A randomized, controlled trial. Eur J Pain. 2016 Feb;20(2):263-73. doi: 10.1002/ejp.719. Epub 2015 Apr 30.
Related InfoLink provided by the sponsor.

Related trials for Acute Low Back Pain

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Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
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Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application
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Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
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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

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nicoboxil, nonivamide + nicoboxil (Finalgon) and nonivamide in people with Acute Low Back Pain, run by Boehringer Ingelheim at 37 sites in Germany.

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 22 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 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany. 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 15 May 2014). 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) Between Pre-dose Baseline and 8hours After First Application (time frame: Baseline and 8 hours after first ointment 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 NCT01708915, which also lists 1 linked publication.

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 29 May 2014.