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The Effect of Spironolactone on Pain in Older People With Osteoarthritis (SPIR-OA)

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ClinicalTrials.gov Identifier: NCT02046668
Recruitment Status : Unknown
Verified January 2014 by Professor Marion E T McMurdo, University of Dundee.
Recruitment status was:  Recruiting
First Posted : January 28, 2014
Last Update Posted : January 29, 2014
Sponsor:
Collaborator:
Arthritis Research UK
Information provided by (Responsible Party):
Professor Marion E T McMurdo, University of Dundee

Brief Summary:
This pilot study will obtain preliminary evidence on which to base sample size calculations for a future trial of whether spironolactone (an aldosterone blocker) reduces knee pain in older people with symptomatic OA knee when given in addition to usual analgesia. Aldosterone is known to be pro-inflammatory, and spironolactone suppresses cytokine production in chronic arthritis. This application builds on previous work by the applicants showing that spironolactone significantly improved quality of life (particularly pain) in frail older people. The investigators will recruit 86 people (aged 70 years or over) with well-defined OA knee to 25mg spironolactone daily or to matching placebo for 12 weeks. The primary outcome is the between group difference in change in WOMAC pain sub-score at 12 weeks. Secondary outcomes are the WOMAC stiffness and physical function subscales and health related quality of life (EQ-5D). Morning cortisol levels will be measured to assess the effect of mineralocorticoid receptor blockade on glucocorticoid levels, which may mediate the anti-inflammatory effect of spironolactone; and urinary CTX-II, and serum matrix metalloproteinase-3 (MMP-3) will be measured as biomarkers as both are sensitive to the effects of pharmacological interventions for osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: spironolactone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Placebo Controlled Trial. The Effect of Spironolactone on Pain in Older People With Osteoarthritis
Study Start Date : November 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: spironolactone
25mg spironolactone daily
Drug: spironolactone
spironolactone 25mg daily for 12 weeks
Other Name: Aldactone

Placebo Comparator: Placebo
Matched Placebo
Drug: spironolactone
spironolactone 25mg daily for 12 weeks
Other Name: Aldactone




Primary Outcome Measures :
  1. Between group difference in change in WOMAC pain subscale (5 items) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Between group difference in change in WOMAC stiffness subscale. [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Between group difference in change in WOMAC physical function subscales. [ Time Frame: 12 weeks ]
  2. Between group difference in change in health-related quality of life measured by EQ-5D questionnaire. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046668


Contacts
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Contact: Roberta DR Littleford, PhD +44 1382 383242 r.littleford@dundee.ac.uk

Locations
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United Kingdom
NHS Fife Not yet recruiting
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Principal Investigator: Vera Cvoro, MbChB, MRCP         
NHS Tayside Recruiting
Dundee, Tayside, United Kingdom, DD1 9SY
Principal Investigator: Miles Witham, BM BCh, MRCP         
Sponsors and Collaborators
University of Dundee
Arthritis Research UK
Investigators
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Study Director: Marion ET McMurdo, MBChB, MD University of Dundee
Principal Investigator: Miles Witham, BM BCh, MRCP University of Dundee
Principal Investigator: Vera Cvoro, Mb CHB, MRCP NHS Fife

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Responsible Party: Professor Marion E T McMurdo, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT02046668     History of Changes
Other Study ID Numbers: 13/WS/0232
2013-002638-19 ( EudraCT Number )
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Professor Marion E T McMurdo, University of Dundee:
Osteoarthritis of knee

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents