Assessment of cognitive function and mobility in individuals with pai
- Conditions
- Everyday pain (treatable with at OTC)Therapeutic area: Body processes [G] - Physical Phenomena [G01]
- Registration Number
- EUCTR2015-002330-42-GB
- Lead Sponsor
- GlaxoSmithKline Consumer Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 65
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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method