The Effect of Spironolactone on Pain in Older People

Phase 1

Conditions: Knee osteoarthritis
MedDRA version: 16.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-002638-19-GB

Lead Sponsor: niversity of Dundee & NHS Tayside

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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 <100mmHg at screening)
j.Significant chronic kidney disease (eGFR<40ml/min)
k.Serum sodium<130mmol/l
l.Serum potassium>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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>To measure blood tests to provide scientific evidence to inform interpretation of the study finding.<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Between group difference in change in WOMAC stiffness subscale<br><br>Between group difference in change in WOMAC physical function subscales<br><br>Between group difference in change in health-related quality of life measured by EQ-5D questionnaire<br>;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks.