Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT04607603
Eligibility Criteria:
Inclusion Criteria:
Patient must be willing and able to give informed consent for participation in the study
* Age 18-80 years
* Knee Pain
* WOMAC Pain Subscale ≥ 5 during screening
* Fulfilment of the clinical criteria of the American College of Rheumatology for knee OA 13
* X-ray or MRI confirmation of knee osteoarthritis
All medications or interventions for pain due to knee osteoarthritis must have been stable for two weeks prior to screening and patient is willing to maintain a stable regimen throughout the study.
Exclusion Criteria:
Exclusion Criteria:
* Current mood disorder (dysthymia, bipolar mood disorder)
* Major Depression \> 12 months (Beck Depression Inventory Score ≥ 18)
* History of a psychoactive substance use disorder within the preceding 12 months
* Major coexisting medical illness (e.g. severe heart failure, pulmonary hypertension, renal insufficiency)
* Glaucoma
* Acute myocardial infarction
* Uncontrolled hypertension
* History of convulsion
* Pregnancy; women of childbearing age will be required to use contraceptives during the duration of the study. Furthermore a pregnancy test will be performed prior to the beginning of the study and once a month during the study period.
* Breast feeding
* Participation in a clinical trial in the 3 weeks preceding the study
* Allergy to study medication
* Recent intra-articular corticosteroid or hyaluronic acid injection in the knee joint. Patients must be willing to abstain from such interventions during the entire study
* Use of the following medication:
* opioids except for tramadol,
* benzodiazepines other than indicated at low doses for sleep disorders
* NSAID
* Corticosteroids
* Impaired kidney function (Creatinine \> 1.5mg/dl)
* Patient has significantly impaired hepatic function defined as any of the following:
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 × upper limit of normal (ULN).
* ALT or AST \>3 × ULN and (total bilirubin \[TBL\] \>2 × ULN or international normalized ratio \[INR\] \>1.5).
* ALT or AST \>3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash,and/or eosinophilia (\>5%).
* Patient is currently using or has in the past used recreational or medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry
* Patient is unwilling to abstain from using recreational or medicinal cannabis, or synthetic cannabinoid based medications during the study
* Patients who are not able to understand the study measures and are not able to complete pain assessment forms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04607603
Study Brief:
Protocol Section:
NCT04607603