Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain
Condition: Acute Pain
MeSH terms: Neck Pain; Acute Pain
Intervention: Diclofenac; Capsaicin; Placebo
Intervention MeSH terms: Diclofenac; Capsaicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 746.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomised, controlled multi-centre parallel group trial will assess the efficacy and
      tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in
      comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of
      acute back pain or neck pain
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed and dated written informed consent at Visit 1 in accordance with Good Clinical
             Practice and local legislation

          -  Male or female patients >=18 years with current diagnosis of acute back pain or of
             neck pain for at least 24 hours, but less than 21 days

          -  Acute back pain or acute neck pain resulting in pain on movement (POM) >= 50 mm
             (Visual Analogue Scale 0-100) for at least one POM procedure out of 5 standardized
             procedures.

          -  Sensitivity to algometric pressure on the painful trigger point <= 25 N/cm2

          -  Women of childbearing potential must be ready and able to use highly effective methods
             of birth control

        Exclusion criteria:

          -  History of 3 or more episodes of back or neck pain in the last 6 months excluding the
             current episode

          -  Surgery due to back or neck pain or rehabilitation due to back or neck pain in the
             last 12 months

          -  Back or neck pain that is attributable to any specific identifiable cause (e.g. disc
             prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic,
             neurological diseases or tumour)

          -  Trauma or strains of the back or neck muscles within the last 3 months

          -  Prior use within the last 3 days before Visit 1 or concomitant use of any
             anti-inflammatory drugs, heparinoids, muscle relaxants or analgesics. Long-acting
             glucocorticoids must have been discontinued 10 days before study entry. Spinal
             injections should have been discontinued in due time (investigator's judgement) before
             patient enrolment to allow complete wash-out of the active ingredient based on
             investigator's judgment

          -  Non-pharmacological treatment (physiotherapy, heat treatment (e.g. heat patch, hot
             water bottle), or massage, acupuncture, transcutaneous electrical nerve stimulation)
             or locally applied pharmacological product to the back or neck area 24 hours prior
             study entry and during the study period

          -  Known severe hepatocellular insufficiency, severe renal insufficiency or Gilbert's
             syndrome (Morbus Meulengracht)

          -  Any other medical condition that would interfere with efficacy and safety assessments
             based on investigator's judgement or any on-going clinical condition that would
             jeopardize patient's or site personnel's safety or study compliance based on
             investigator judgement.

          -  Known intolerance or hypersensitivity to the active ingredients or any excipient(s).

          -  Patients in whom attacks of asthma, bronchospasm, rhinitis or urticaria were
             precipitated by the intake of Acetyl salicylic acid (ASS) or other NSAIDs

          -  Irritated skin (based on investigator's judgement), skin wounds, eczema or open
             injuries at application site

          -  Negative experience in the past with heat treatments for muscle complaints

          -  Patient not able to understand and comply with trial requirements based on
             investigators judgement

          -  Alcohol or drug abuse

          -  Participation in a clinical trial within the previous 30 days or simultaneous
             participation in another clinical trial

          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial