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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01420666
Eligibility Criteria:
Inclusion Criteria:
* Provides written informed consent before initiation of any study-related procedures.
* Have had symptoms of OA of the knee or hip for at least 6 months that has required analgesic medication.
* Have confirmed radiological evidence of OA.
* Be between 45 - 80 years of age inclusive, on the day of consent.
* In the opinion of a physician, require long term medication for treatment of painful OA.
* Have painful OA of the knee or hip with a pain score of at least 40 mm and no more than 80 mm on the WOMAC VAS pain scale at rest following a 3 - 7 day washout of existing analgesics.
Exclusion Criteria:
* Weigh less than 50 kg
* Rheumatoid arthritis or other inflammatory arthritis.
* Gout or recurrent episodes of pseudogout.
* Paget's disease.
* Articular fracture.
* Ochronosis.
* Acromegaly.
* Haemochromatosis.
* Wilson's Disease.
* Primary Osteochondromatosis.
* Heritable disorders (e.g. hypermobility).
* Have received or taken oral or parenteral corticosteroids within 2 months or intra-articular hyaluronic acid within 9 months.
* Has taken any single dose of an NSAID or acetaminophen within 12 hours prior to first dose of study drug
* Known to be pregnant or possibly pregnant
* Women of childbearing potential who, in the opinion of the investigator, are not using reliable contraception.
* Alcohol intake in excess of 14 units per week for females and 21 units per week for males.
* Have a history of drug abuse.
* Suffering from a neurological disorder relating to pain perception.
* In the opinion of the investigator, unable to understand the visual analogue pain score.
* Currently, or in the last 30 days, participating in a clinical trial involving another study drug.
* Suffering from any other diseases or conditions which, in the opinion of the investigator, means that it would not be in the patients best interests to participant in this study.
* Hypersensitivity to aspirin or other NSAID
* Hypersensitivity to acetaminophen
* Severe known haemopoietic, renal or hepatic disease, immunosuppression
* History of gastric ulceration, indigestion, stomach pain or GI bleeding or bleeding disorders
* Currently suffering from dehydration through diarrhoea and/or vomiting
* History of severe asthma defined as previous steroid treatment or hospital admission within the last 5 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT01420666
Study Brief:
Protocol Section:
NCT01420666