Condition category
Musculoskeletal Diseases
Date applied
15/01/2010
Date assigned
03/02/2010
Last edited
24/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chi Hung Cheng

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Prednisolone, indometacin

Primary outcome measures

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 trial start date

01/01/2010

Overall trial end date

31/12/2011

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26903390

Publication citations

Additional files

Editorial Notes

24/02/2016: Publication reference added.