Difference in indometacin and prednisolone in the treatment of gouty arthritis

ISRCTN	ISRCTN45724113
DOI	https://doi.org/10.1186/ISRCTN45724113
Protocol serial number	CRE-2008.466-T
Sponsor	Health, Welfare and Food Bureau (Hong Kong)
Funder	Health and Health Services Research Fund (HHSRF) (Hong Kong) - Special Administrative Region

Submission date: 15/01/2010
Registration date: 03/02/2010
Last edited: 24/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chi Hung Cheng
Scientific

Accident and Emergency Medicine Academic Unit
The Chinese University of Hong Kong
Prince of Wales Hospital
Shatin, NT
852
Hong Kong

Study information

Primary study design	Interventional
Study design	Multicentre double-blind randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparison of oral prednisolone and oral indometacin in the treatment of acute gout-like arthritis: a multicentre double-blind randomised trial
Study objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Prednisolone, indometacin
Primary outcome measure(s)	Charted daily up to 14 days after the medication started: 1. Analgesic efficacy 2. Presence or absence of adverse effects
Key secondary outcome measure(s)	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
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	400
Key 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.
Key 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.
Date of first enrolment	01/01/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Hong Kong

Study participating centre

The Chinese University of Hong Kong

Shatin, NT
852
Hong Kong

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/04/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/02/2016: Publication reference added.