Knee osteoarthritis MedDRA version: 16.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Spironolactaone
Product Name: Spironolactone
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Spironolactone
CAS Number: 52017
Concentration unit: mg milligram(s)
Concentration type
Sponsors
University of Dundee & NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Participant is willing and able to give informed consent. b. Community dwelling c. Aged 70 years and over d. 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) e. To avoid floor effects, participants will require to have moderate (or more severe) pain at baseline in at least 2 out of 5 WOMAC pain score items f. To have been in receipt of one or more analgesic agents at a therapeutic dose for at least 2 months g. Willing to have knee x-ray if one has not been taken in preceding 12 months Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 86
Exclusion criteria
Exclusion criteria: a. Clinical diagnosis of symptomatic heart failure b. History of inflammatory arthritis c. Already taking spironolactone d. Previous intolerance to spironolactone e. Known allergies to spironolactone or lactose f. Objection to taking capsules made from animal sourced gelatine g. Taking oral NSAIDs (because of the increased risk of renal impairment when combined with spironolactone) h. 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. i. Supine hypotension (supine systolic blood pressure 5.0mmol/l m. Symptomatic orthostatic hypotension (measured at screening) n. Nursing home resident o. Wheelchair bound p. Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study q. Known contraindication to spironolactone therapy r. Participant who is terminally ill, defined as less than 3 months expected survival
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This pilot study’s purpose it to provide preliminary evidence on which to base sample size calculations for a possible future trial which will answer the question: “Is spironolactone more effective than placebo in reducing knee pain in older people with symptomatic osteoarthritis (OA) of the knee, when given in addition to usual analgesia?”;Secondary Objective: To obtain preliminary evidence and data on whether oral spironolactone therapy improves health-related quality of life compared to placebo in older people with knee OA. To measure blood tests to provide scientific evidence to inform interpretation of the study finding. ;Primary end point(s): Between group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (5 items) at 12 weeks;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Between group difference in change in WOMAC stiffness subscale Between group difference in change in WOMAC physical function subscales Between group difference in change in health-related quality of life measured by EQ-5D questionnaire ;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks. | — |
Countries
United Kingdom
Contacts
Public ContactMcMurdo
University of Dundee
Outcome results
None listed