| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Everyday pain (treatable with at OTC) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Head ache or other bodily pain treatable with OTC medication |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To investigate cognitive function in individuals suffering from everyday pain and compare with their cognitive function when pain-free. |
|
| E.2.2 | Secondary objectives of the trial |
| To investigate mobility in individuals suffering from everyday pain and compare with their mobility when pain-free. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Consent:
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.
Age:
Between 18-65 years.
Gender:
Subject is male or female.
If female of childbearing potential subject is practicing a reliable method of contraception in the opinion of the investigator. For the purposes of this study, adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
Compliance:
Understands and is willing, able and likely to comply with all study procedures and restrictions.
Completion of familiarisation tasks:
Adequately completes cognition and mobility familiarisation tasks in the opinion of the investigator.
General health:
Good general and mental health with, in the opinion of the investigator or medically qualified designee:
A. No clinically significant and relevant abnormalities in medical history or upon physical examination.
B. Absence of any condition that might impact on the subject’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
C. BMI equal or greater than 18.5 to equal or less than 30 kg/m2.
Pain type and intensity:
A. 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.
B. VISIT 2 ONLY – A score ≥5 to question 6 (rated on scale 0-10) on the Brief
Pain Inventory – Short Form.
C. Subjects presenting with only one of the following pain types: Joint (Knee,
Hip); Back; Headache; Period. |
|
| E.4 | Principal exclusion criteria |
Pregnancy:
A. Women who are pregnant (Visit 1).
B. Women of child bearing potential who test positive on a urine pregnancy test (Visit 1 or Visit 2).
Breast-feeding:
Women who are currently breast-feeding.
General health:
In the opinion of the medical designee, subject 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.
Colour blind:
Subject is colour blind.
Concurrent medication/ medical history:
A. 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.
B. 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).
C. Use of analgesics and anti-inflammatory drugs 48 hours prior to dosing at
Visit 2.
D. Known to be taking any other medication which could counteract with
paracetamol and/or caffeine.
E. Current or past use of anti-depressants or psychoactive drugs within the previous 2-years.
Allergy/ Intolerance:
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Substance abuse:
A. Positive breath alcohol test at Visit 2.
B. Positive urine drugs of abuse test at Visit 2.
Clinical study/ experimental product
A. Participation in another clinical study (including cosmetic studies) or receipt of an investigational product within 7 days of the screening visit.
B. Previous participation in this study.
Lifestyle:
A. Subject has excessive frequent caffeine intake equivalent to 6 cups of brewed coffee or 12 cups of tea per day.
B. Unwilling to abstain from any caffeine products prior to the visit on assessment days (Visit 2 and 3).
C. Current Smoker (or regular nicotine consumption): Subject smokes more than
3 cigarettes per day (or equivalent for e-cigarettes, chewing tobacco or pipes).
Investigator to ensure there is no impact of withdrawal effect from those with
nicotine dependence.
D. Current Alcohol Consumer: Subject 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).
Personnel:
Members of the study site staff or members of their immediate family.
Investigator's opinion:
Any subject who in the opinion of the investigator should not take part in this study. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Subject level change from pain-free state in cognition as measured by cognitive function assessment (CANTAB and Axon Sports) in the pain state. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
Subject level change from painfree state in mobility as measured by gait, time to standing and grip force score in the pain state.
Exploratory:
Correlation between pain intensity and each cognitive assessment for each pain type at Visit 2 Pre and Visit 2 Post.
Correlation between pain intensity and each mobility assessment for each pain type at
Visit 2 Pre and Visit 2 Post.
Effect of intervention on change from pain-state assessment in cognition as measured by cognitive function assessment (CANTAB and Axon Sports) to post-treatment assessment period.
Effect of intervention on change from pain-state assessment in mobility as measured by gait score, time to standing score and change of muscle score to post-treatment
assessment period. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | 14 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 14 |
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