Exploratory Study to Investigate Cognition Function and Mobility in Individuals With Pain
Condition: Pain
Intervention: Paracetamol and caffeine; Paracetamol; Placebo
Intervention description: Test product containing 500 mg paracetamol and 65 mg caffeine; Test product containing 500 mg paracetamol; Placebo to match paracetamol 665mg sustained release tablets
Intervention MeSH terms: Acetaminophen; Caffeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This parallel, assessor blind, placebo-controlled, stratified, randomized study will
      investigate the effects of everyday pain on cognition and mobility in otherwise healthy
      individuals.
    

Eligibility criteria:

        Inclusion Criteria

          -  Demonstrates understanding of the study procedures, restrictions and willingness to
             participate as evidenced by voluntary written informed consent and has received a
             signed and dated copy of the informed consent form.

          -  Aged between 18-65 years.

          -  Participant is male or female.

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions.

          -  Adequately completes cognition and mobility familiarisation tasks in the opinion of
             the investigator.

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee: No clinically significant and relevant abnormalities in medical
             history or upon physical examination; absence of any condition that might impact on
             the participant's safety or wellbeing or affect the individual's ability to understand
             and follow study procedures and requirements; BMI >18.5 and <30 kg/m2

          -  VISIT 1 ONLY - Has experienced a minimum of two recurrent, acute pain episodes within
             the past 3 months or is currently suffering from a flare up episode of recurrent,
             acute pain; VISIT 2 ONLY - A score ≥5 to question 6 (rated on scale 0-10) on the Brief
             Pain Inventory - Short Form and participants presenting with only one of the following
             pain types: Joint (Knee, Hip); Back; Headache; Period.

        Exclusion Criteria

          -  Women who are pregnant (Visit 1), women of child bearing potential who test positive
             on a urine pregnancy test (Visit 1 or Visit 2), females of non-child bearing potential
             will not be required to complete urinary pregnancy test, post-menopausal females not
             requiring a pregnancy test will be defined as: Age ≥ 50 years with spontaneous
             cessation of menses for 12 or more months or age < 55 years and spontaneous menses
             within the past 1 year, but currently amenorrheic.

          -  Women who are currently breast-feeding.

          -  In the opinion of the medical designee, participant suffers from medical condition(s)
             that may be aggravated due to testing procedures or may impact the interpretation or
             integrity of data. Conditions related to renal, hepatic, respiratory, blood, immune
             systems or heart dysfunction will be considered.

          -  Participant is colour blind.

          -  Current (within 14 days of the start of the study) or regular use of any prescription,
             over-the-counter (OTC), herbal medicine unless the medication has been approved by the
             study physician. OTC analgesics for pain relief and vitamin supplements are permitted
             only until 48 hours prior to study visits; Current or in the 30 days prior to dosing
             use of any drug, food, herbal product, or dietary supplement known to induce or
             inhibit hepatic drug metabolism (e.g. barbiturates, theophylline, cimetidine, or
             erythromycin) ;Use of analgesics and anti-inflammatory drugs 48 hours prior to dosing
             at Visit 2; Known to be taking any other medication which could counteract with
             paracetamol and/or caffeine; Current or past use of anti-depressants or psychoactive
             drugs within the previous 2-years.

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients.

          -  Positive breath alcohol test at Visit 2 and positive urine drugs of abuse test at
             Visit 2.

          -  Participation in another clinical study (including cosmetic studies) or receipt of an
             investigational product within 7 days of the screening visit or previous participation
             and randomization in this study.

          -  Participant has excessive frequent caffeine intake equivalent to 6 cups of brewed
             coffee or 12 cups of tea per day; Unwilling to abstain from any caffeine products from
             4 hours prior to the visit on assessment days (Visit 2 and 3); Current Smoker (or
             regular nicotine consumption): Participant smokes more than 3 cigarettes per day (or
             equivalent for e-cigarettes, chewing tobacco or pipes). Investigator will ensure there
             is no impact of withdrawal effect from those with nicotine dependence; Current Alcohol
             Consumer: Participant consumes greater than 21 units of alcohol per week (male) and 14
             units per week (female) (e.g. Spirit 25ml = 1 unit / AlcoPop 275ml = 1.5 unit / Bottle
             of beer 330 ml = 1.7 unit / Glass of wine 175ml = 2.1 unit / Pint of beer 568 ml = 3
             unit).

          -  Members of the study site staff or members of their immediate family.

          -  Any participant who in the opinion of the investigator should not take part in this
             study.