Difference in indometacin and prednisolone in the treatment of gouty arthritis
| ISRCTN | ISRCTN45724113 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45724113 |
| Secondary identifying numbers | CRE-2008.466-T |
- 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
Not provided at time of registration
Contact information
Dr Chi Hung Cheng
Scientific
Scientific
Accident and Emergency Medicine Academic Unit
The Chinese University of Hong Kong
Prince of Wales Hospital
Shatin, NT
852
Hong Kong
Study information
| Study design | Multicentre double-blind randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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 |
| 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 |
Eligibility
| 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 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 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
852
Hong Kong
Sponsor information
Health, Welfare and Food Bureau (Hong Kong)
Government
Government
Research Office
Government Secretariat
18/F, Murray Building
Garden Road
-
852
Hong Kong
| Website | http://www.fhb.gov.hk/en/index.html |
|---|---|
"ROR" |
https://ror.org/03qh32912 |
Funders
Funder type
Government
Health and Health Services Research Fund (HHSRF) (Hong Kong) - Special Administrative Region
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
24/02/2016: Publication reference added.
