Osteoarthritis, KneePhase 4SPIR-OANCT02046668
The Effect of Spironolactone on Pain in Older People With Osteoarthritis
A Phase 4 study testing spironolactone in people with Osteoarthritis, Knee, run by University of Dundee at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2013to May 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participant is willing and able to give informed consent
- Community dwelling
- Aged 70 years and over
- 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)
- 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
- 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
- Willing to have knee x-ray if one has not been taken in preceding 12 months
Who cannot join
- Clinical diagnosis of symptomatic heart failure
- History of inflammatory arthritis
- Already taking spironolactone
- Previous intolerance to spironolactone
- Known allergies to spironolactone or lactose
- Objection to taking capsules made from animal sourced gelatine
Show all 18Show fewer
- Taking oral NSAIDs (because of the increased risk of renal impairment when combined with spironolactone)
- 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.
- Supine hypotension (supine systolic blood pressure <100mmHg at screening)
- Significant chronic kidney disease (eGFR<40ml/min)
- Serum sodium<130mmol/l
- Serum potassium>5.0mmol/l
- Symptomatic orthostatic hypotension (measured at screening)
- Nursing home resident
- Wheelchair bound
- Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
- Known contraindication to spironolactone therapy
- Participant who is terminally ill, defined as less than 3 months expected survival
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS Tayside
Dundee, Tayside, DD1 9SY
NHS Fife
Kirkcaldy, Fife, KY2 5AH
About this study
Official title: A Randomised Placebo Controlled Trial. The Effect of Spironolactone on Pain in Older People With Osteoarthritis
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- spironolactone
- Keywords
- Osteoarthritis of knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spironolactoneDrug
Also called Aldactone
spironolactone 25mg daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| spironolactone | Active comparator | 25mg spironolactone daily Receives: Drug: spironolactone |
| Placebo | Placebo comparator | Matched Placebo Receives: Drug: spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group difference in change in WOMAC pain subscale (5 items)
Measured: 12 weeks
Secondary outcomes (1)
Between group difference in change in WOMAC stiffness subscale.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK
- Responsible party
- Sponsor
- Investigators
- Marion ET McMurdo, MBChB, MD, Study director, University of DundeeMiles Witham, BM BCh, MRCP, Principal investigator, University of DundeeVera Cvoro, Mb CHB, MRCP, Principal investigator, NHS Fife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046668
- Sponsor's protocol ID
- 13/WS/0232
- Other IDs
- 2013-002638-19
- Acronym
- SPIR-OA
- Status last verified
- Oct 2019
- First submitted
- 24 Jan 2014
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo Controlled Trial. The Effect of Spironolactone on Pain in Older People With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02046668
- Acronym / sponsor ID
- SPIR-OA / 13/WS/0232
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis of knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Arthritis Research UK
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spironolactone | Active comparator | Drug: spironolactone25mg spironolactone daily |
| Placebo | Placebo comparator | Drug: spironolactoneMatched Placebo |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent
- Community dwelling
- Aged 70 years and over
- 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)
- 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
Key exclusion criteria (18 listed)
- Clinical diagnosis of symptomatic heart failure
- History of inflammatory arthritis
- Already taking spironolactone
- Previous intolerance to spironolactone
- Known allergies to spironolactone or lactose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spironolactoneAlso: Aldactonespironolactone 25mg daily for 12 weeks | Drug | Placebo, spironolactone |
Primary outcome
Between group difference in change in WOMAC pain subscale (5 items)
Time frame: 12 weeks
1 secondary outcome
Between group difference in change in WOMAC stiffness subscale.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion ET McMurdo, MBChB, MD study director
University of Dundee
Miles Witham, BM BCh, MRCP principal investigator
University of Dundee
Vera Cvoro, Mb CHB, MRCP principal investigator
NHS Fife
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing spironolactone in people with Osteoarthritis, Knee, run by University of Dundee at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group difference in change in WOMAC pain subscale (5 items) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.