Ibuprofen/Caffeine Lower Back or Neck Pain Study
Condition: Back Pain; Neck Pain
MeSH terms: Neck Pain
Intervention: ibuprofen; caffeine; placebo
Intervention MeSH terms: Ibuprofen; Caffeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 635.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison
      to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess
      the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a
      400 mg ibuprofen tablet and a placebo tablet.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed and dated written informed consent at Visit 1 in accordance with Good Clinical
             Practice (GCP) and local legislation.

          -  Male or female patients who are >=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) >=5 on the 0-10
             Numerical Rating Scale (NRS) for at least one POM procedure out of 5 standardised
             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.

          -  Reliable, cooperative, and of adequate intelligence to record the requested
             information on the analgesic questionnaires.

          -  Examined by the attending physician and medically cleared to participate in the study

          -  In good general health, with a body mass index (BMI) < 30, and have no
             contraindications to any of the study medication

        Exclusion criteria:

          -  History of 3 or more episodes of back or neck pain in the last 6 months excluding the
             current episode.

          -  Patients with pain at rest >= 9

          -  Patient with chronic back or neck pain as defined as pain for 3 weeks or longer.

          -  Back or neck pain that is attributable to any identifiable cause (eg. disc prolapse,
             spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological
             diseases or tumour)

          -  Any strains of the back or neck muscles documented by clinical evaluation and
             anamnesis that occurred 21 days to 3 months prior to the screening visit.

          -  Surgery due to back or neck pain or rehabilitation due to back or neck pain in the
             last 12 months.

          -  Prior use within the last 3 days before Visit 1 or concomitant use of any anti-
             inflammatory drugs, heparinoids, muscle relaxants or analgesics (including but not
             limited to short-acting glucocorticoids, non-steroidal anti-inflammatory drugs
             [NSAIDs], herbal preparations) for the same indication or other indications.

          -  Spinal injections should have been discontinued in due time (investigator's judgment)
             before patient enrollment to allow complete wash-out of the active ingredient based on
             investigator's judgment.

          -  Known severe hepatocellular insufficiency, severe renal insufficiency or Gilbert's
             syndrome (Morbus Meulengracht)

          -  Patients taking Central Nervous System (CNS) or other psychotropic drugs, or any
             nutritional supplement known to have psychotropic effects such as St. John's Wort,
             Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal Skullcap, or Valerian
             within two months of taking the first dose of study medication. Patients who have been
             on stable doses of these medications for at least two months will be allowed into the
             study, as long as they maintain this dose throughout the study, and their condition is
             judged stable by the Principal Investigator

          -  Any other medical condition that would interfere with efficacy and safety assessments
             based on investigator's judgment or any on-going clinical condition that would
             jeopardize patient's or site personnel's safety or study compliance based on
             investigator judgment

          -  Further exclusion criteria apply