BridgeMD
Pragmatic, randomized, multicentric, double-blind, controlled clinicial trial on the treatment of acute gout attacks with prednisolone versus colchicine in primary care (COPAGO)
EU CTIS ID: 2024-514738-18-00
What this study is testing
Most severe pain in the last 24 hours (measured with an 11-point numerical rating scale, day 3 after baseline)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients aged 18 years and over
- Acute pain in the hand or foot (podagra, chiragra)
- onset of pain was no more than 2 calendar days ago
- Clinical diagnosis acute attack of gout
- willingness to participate in the study and ability to give written informed consent
You likely can't join if
- Known intolerance to the investigational or comparator product or existing contraindication according to the prescribing information
- Known HIV infection
- Solid organ transplant with immunosuppression
- Desire to have children within the next 6 months for men and women
- Pregnancy or breastfeeding
- participation in other studies in the last 3 months
See the full eligibility criteria
- Adult patients aged 18 years and over
- Acute pain in the hand or foot (podagra, chiragra)
- onset of pain was no more than 2 calendar days ago
- Clinical diagnosis acute attack of gout
- willingness to participate in the study and ability to give written informed consent
- Known intolerance to the investigational or comparator product or existing contraindication according to the prescribing information
- Known HIV infection
- Solid organ transplant with immunosuppression
- Desire to have children within the next 6 months for men and women
- Pregnancy or breastfeeding
- participation in other studies in the last 3 months
- Participation in the COPAGO study with a past gout attack
- Known intolerance to the placebos (e.g. lactose intolerance)
- Existing or less than 2 weeks previous oral treatment with corticosteroids or colchicine
- Known chronic kidney disease (from CKD stage 4) or available value of eGFR < 30ml/min/1.73 m²
- Known dyshematopoiesis or available values of thrombocytes < 30,000 µl or leukocytes < 4000 µl, or Hb < 5 mmol/l or 8 g/dl
- Uncontrolled high blood pressure (systolic blood pressure permanently above 160 mmHg)
- Known liver cirrhosis or severe liver disease or available liver values SGOT and SGPT increased by more than twice the respective reference range
- Known, current gastric or duodenal ulcer (diagnosed in the last 4 weeks)
- Current chemotherapy or chemotherapy completed less than 3 months ago
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.