Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CRE-2008.466-T
Study information
Scientific title
Comparison of oral prednisolone and oral indometacin in the treatment of acute gout-like arthritis: a multicentre double-blind randomised trial
Acronym
Study hypothesis
Oral prednisolone is as effective as indometacin in treating gouty arthritis with less side effects.
Ethics approval(s)
The Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee, 19/12/2008, ref: CRE-2008.466-T
Study design
Multicentre double-blind randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gouty arthritis
Intervention
In Group 1 each patient will initially receive indometacin 50 mg orally, and six tablets of prednisolone-like placebo orally, and will then be observed for 120 minutes. Subsequently, the patient will be given a five day prescription of indometacin (50 mg orally eight hourly for two days follow by indometacin 25 mg eight hourly for another three days), and six tablets of prednisolone-like placebo once a day.
In Group 2 each patient will initially receive prednisolone 30 mg (six 5 mg tablets) orally, and indometacin-like placebo (two tablets) orally, and will then be observed for 120 minutes. After the initial treatment and observation, the patient will then be given a five day prescription of indometacin-like placebo (two tablets eight hourly for two days follow by one tablet eight hourly for a further three days) and prednisolone 30 mg orally once per day for five days.
All patients will be prescribed paracetamol 1 g six-hourly to be taken as required.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Prednisolone, indometacin
Primary outcome measure
Charted daily up to 14 days after the medication started:
1. Analgesic efficacy
2. Presence or absence of adverse effects
Secondary outcome measures
Charted daily up to 14 days after the medication started:
1. 36-item Short Form health survey (SF-36) score
2. Joint stiffness
3. Joint swelling
4. Joint tenderness
5. Length of hospital stay
6. Paracetamol use
7. Relapse rate within 14 days
Overall study start date
01/01/2010
Overall study end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than 18 years, either sex
2. Presenting to the Emergency Department between 9 am and 4 pm, Monday to Friday, from 1st January 2010 to 31st December 2011 with an acute arthritis suggestive of gout
3. Present within 3 days of symptom onset
4. Have a clinical diagnosis of an acute monoarthritis suggestive of gout
5. For the purpose of this study the diagnosis of acute gout is made if BOTH of the following TWO criteria are met:
5.1. Criteria 1: The presence of rapid onset of severe pain, swelling, tenderness and erythema of an affected joint, which is maximal by 6 to 12 hours
5.2. Criteria 2: The presence of one or more of the following:
5.2.1. Metatarsal-phalangeal (MTP) joint involvement (podagra); or
5.2.2. Knee or ankle joint involvement; or wrist or elbow joint involvement WITH either:
5.2.2.1. Gouty tophi present, or
5.2.2.2. Previous joint aspiration confirming the diagnosis of gout, or
5.2.2.3. The presence of hyperuricaemia, or
5.2.2.4. A clinical history of one or more clinical gouty arthritis attack
If none of B1 to B4 is present then we will seek to confirm the diagnosis by visual and microscopic examination of joint aspirate containing crystals.
Although joint aspiration and confirmation of the presence of uric acid crystals is not mandatory for inclusion in this study, nevertheless every patient will be asked whether they will consent to joint aspiration. Records will be kept of those that do and do not agree, and of those patients where aspiration is successful or unsuccessful.
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
100 per centre, total of 400
Participant exclusion criteria
1. Suspicion of sepsis or other joint disease (e.g. rheumatoid arthritis)
2. Follow up is not possible because of lack of transport or lack of telephone contact
3. Any significant co-morbidity which would interfere with assessment
4. Dementia
5. Confusion
6. Active gastrointestinal symptoms
7. Renal insufficiency with serum creatinine greater than 200 umol/L
8. Bleeding disorder
9. Warfarin
10. Allergy to a study drug
11. Joint aspirate which excluded the diagnosis of gout
It is often not possible to definitively separate gout from septic arthritis on clinical grounds alone, but for this study, sepsis is likely if the patient has a temperature greater than 38°C, chills or rigors, a wound near to the affected joint, a history of immunosuppression, erythematous tracking along a lymphatic vessel or vein in the affected limb, lymphadenopathy, or a previous history of septic arthritis.
Recruitment start date
01/01/2010
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Hong Kong
Study participating centre
The Chinese University of Hong Kong
Shatin, NT
852
Hong Kong
Sponsor information
Organisation
Health, Welfare and Food Bureau (Hong Kong)
Sponsor details
Research Office
Government Secretariat
18/F
Murray Building
Garden Road
-
852
Hong Kong
Sponsor type
Government
Website
http://www.fhb.gov.hk/en/index.html
ROR
Funders
Funder type
Government
Funder name
Health and Health Services Research Fund (HHSRF) (Hong Kong) - Special Administrative Region
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/04/2016 | Yes | No |