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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT02046668
Eligibility Criteria:
Inclusion Criteria:
1. Participant is willing and able to give informed consent
2. Community dwelling
3. Aged 70 years and over
4. Symptomatic idiopathic OA knee according to American College of Rheumatology clinical and radiographic criteria (ie Knee pain - with or without crepitus and presence of osteophytes on x ray)
5. To avoid floor effects, participants will require to have moderate (or more severe) pain at screening in at least 2 out of 5 WOMAC pain score items
6. To have been in receipt (prescription or/and over the counter) of one or more analgesic agents at a therapeutic dose for at least 2 months
7. Willing to have knee x-ray if one has not been taken in preceding 12 months
Exclusion Criteria:
1. Clinical diagnosis of symptomatic heart failure
2. History of inflammatory arthritis
3. Already taking spironolactone
4. Previous intolerance to spironolactone
5. Known allergies to spironolactone or lactose
6. Objection to taking capsules made from animal sourced gelatine
7. Taking oral NSAIDs (because of the increased risk of renal impairment when combined with spironolactone)
8. Taking ACE inhibitors or ARBs (angiotensin II receptor antagonists). ARBs have many properties similar to those of ACE inhibitors. Both will be exclusion because of the increased risk of acute kidney injury and hyperkalaemia, and because our previous study also excluded those on ACE inhibitors (and ARBs) and treatment was safe and well tolerated.
9. Supine hypotension (supine systolic blood pressure \<100mmHg at screening)
10. Significant chronic kidney disease (eGFR\<40ml/min)
11. Serum sodium\<130mmol/l
12. Serum potassium\>5.0mmol/l
13. Symptomatic orthostatic hypotension (measured at screening)
14. Nursing home resident
15. Wheelchair bound
16. Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
17. Known contraindication to spironolactone therapy
18. Participant who is terminally ill, defined as less than 3 months expected survival
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02046668
Study Brief:
Protocol Section:
NCT02046668