Nonivamide/Nicoboxil Ointment in Acute Low Back Pain
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: nicoboxil; placebo matching nonivamide + nicoboxil; nonivamide + nicoboxil (Finalgon); nonivamide
Intervention description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period; 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period; 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period; 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Intervention MeSH terms: Nicotinic Acids; Capsaicin; Nonivamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 805.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

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