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Difference in indometacin and prednisolone in the treatment of gouty arthritis

Comparison of oral prednisolone and oral indometacin in the treatment of acute gout-like arthritis: a multicentre double-blind randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45724113
Enrollment
400
Registered
2010-02-03
Start date
2010-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gouty arthritis Musculoskeletal Diseases Gout

Interventions

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

Sponsors

Health, Welfare and Food Bureau (Hong Kong)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Charted daily up to 14 days after the medication started: 1. Analgesic efficacy 2. Presence or absence of adverse effects

Secondary

MeasureTime frame
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

Countries

Hong Kong

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026