Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

NCT ID: NCT01708915

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 805 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-04-30

Brief 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.

Conditions

Acute Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

nonivamide + nicoboxil (Finalgon)

Intervention Type: DRUG

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

nonivamide

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

Group Type: ACTIVE_COMPARATOR

nonivamide

Intervention Type: DRUG

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

nicoboxil

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

Group Type: ACTIVE_COMPARATOR

nicoboxil

Intervention Type: DRUG

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

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo matching nonivamide + nicoboxil

Intervention Type: DRUG

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

Interventions

nicoboxil

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

Intervention Type: DRUG

placebo matching nonivamide + nicoboxil

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

Intervention Type: 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

Intervention Type: DRUG

nonivamide

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

69.52.49007 Boehringer Ingelheim Investigational Site

Bad Lippspringe, , Germany

69.52.49003 Boehringer Ingelheim Investigational Site

Berlin, , Germany

69.52.49004 Boehringer Ingelheim Investigational Site

Berlin, , Germany

69.52.49026 Boehringer Ingelheim Investigational Site

Berlin, , Germany

69.52.49032 Boehringer Ingelheim Investigational Site

Berlin, , Germany

69.52.49033 Boehringer Ingelheim Investigational Site

Berlin, , Germany

69.52.49041 Boehringer Ingelheim Investigational Site

Berlin, , Germany

69.52.49027 Boehringer Ingelheim Investigational Site

Cologne, , Germany

69.52.49035 Boehringer Ingelheim Investigational Site

Cologne, , Germany

69.52.49040 Boehringer Ingelheim Investigational Site

Cologne, , Germany

69.52.49002 Boehringer Ingelheim Investigational Site

Einbeck, , Germany

69.52.49024 Boehringer Ingelheim Investigational Site

Essen, , Germany

69.52.49031 Boehringer Ingelheim Investigational Site

Essen, , Germany

69.52.49036 Boehringer Ingelheim Investigational Site

Essen, , Germany

69.52.49005 Boehringer Ingelheim Investigational Site

Everswinkel, , Germany

69.52.49039 Boehringer Ingelheim Investigational Site

Fürth, , Germany

69.52.49018 Boehringer Ingelheim Investigational Site

Goch, , Germany

69.52.49025 Boehringer Ingelheim Investigational Site

Großheirath-Rossach, , Germany

69.52.49022 Boehringer Ingelheim Investigational Site

Haag, , Germany

69.52.49009 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

69.52.49019 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

69.52.49015 Boehringer Ingelheim Investigational Site

Kaarst, , Germany

69.52.49042 Boehringer Ingelheim Investigational Site

Karlsruhe-Rüppurr, , Germany

69.52.49013 Boehringer Ingelheim Investigational Site

Köthen, , Germany

69.52.49014 Boehringer Ingelheim Investigational Site

Künzing, , Germany

69.52.49034 Boehringer Ingelheim Investigational Site

Ludwigshafen, , Germany

69.52.49028 Boehringer Ingelheim Investigational Site

Messkirch, , Germany

69.52.49030 Boehringer Ingelheim Investigational Site

Messkirch, , Germany

69.52.49029 Boehringer Ingelheim Investigational Site

Münster, , Germany

69.52.49012 Boehringer Ingelheim Investigational Site

Neunkirchen, , Germany

69.52.49020 Boehringer Ingelheim Investigational Site

Rodgau, , Germany

69.52.49037 Boehringer Ingelheim Investigational Site

Siegen, , Germany

69.52.49016 Boehringer Ingelheim Investigational Site

Stockach, , Germany

69.52.49010 Boehringer Ingelheim Investigational Site

Straßkirchen, , Germany

69.52.49021 Boehringer Ingelheim Investigational Site

Villingen-Schwenningen, , Germany

69.52.49023 Boehringer Ingelheim Investigational Site

Wangen, , Germany

69.52.49011 Boehringer Ingelheim Investigational Site

Weilburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 25929250 (View on PubMed)

Other Identifiers

2011-003890-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

69.52

Identifier Type: -

Identifier Source: org_study_id