Pragmatic, randomized, multicentric, double-blind, controlled clinicial trial on the treatment of acute gout attacks with prednisolone versus colchicine in primary care (COPAGO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsmedizin Greifswald KöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

12 Jan 2023 → 28 Feb 2026

Decision date (initial)

2024-09-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514738-18-00

EudraCT number

2021-005556-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Most severe pain in the last 24 hours (measured with an 11-point numerical rating scale, day 3 after baseline)

Secondary objectives 6

1. - the average response to treatment from day 1 - 6 of follow-up
2. - Swelling and tenderness of the joint (measured with 4-point Likert scale, day 3 after baseline)
3. - Physical function on day 6 compared to baseline
4. - Overall assessment of treatment success by patients, (measured with 5-point Likert scale, day 6 after baseline)
5. - Frequency of taking additional pain medication per treatment group
6. - Frequency of use of non-drug pain therapies in the treatment groups

Conditions and MedDRA coding

gout, acute gout attack

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adult patients aged 18 years and over
2. Acute pain in the hand or foot (podagra, chiragra)
3. onset of pain was no more than 2 calendar days ago
4. Clinical diagnosis acute attack of gout
5. willingness to participate in the study and ability to give written informed consent

Exclusion criteria 15

1. Known intolerance to the investigational or comparator product or existing contraindication according to the prescribing information
2. Known intolerance to the placebos (e.g. lactose intolerance)
3. Existing or less than 2 weeks previous oral treatment with corticosteroids or colchicine
4. Known chronic kidney disease (from CKD stage 4) or available value of eGFR < 30ml/min/1.73 m²
5. Known dyshematopoiesis or available values of thrombocytes < 30,000 µl or leukocytes < 4000 µl, or Hb < 5 mmol/l or 8 g/dl
6. Uncontrolled high blood pressure (systolic blood pressure permanently above 160 mmHg)
7. Known liver cirrhosis or severe liver disease or available liver values SGOT and SGPT increased by more than twice the respective reference range
8. Known, current gastric or duodenal ulcer (diagnosed in the last 4 weeks)
9. Current chemotherapy or chemotherapy completed less than 3 months ago
10. Known HIV infection
11. Solid organ transplant with immunosuppression
12. Desire to have children within the next 6 months for men and women
13. Pregnancy or breastfeeding
14. participation in other studies in the last 3 months
15. Participation in the COPAGO study with a past gout attack

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Most severe pain in the last 24 hours

Secondary endpoints 7

1. average response to treatment from day 1 - 6 of follow-up
2. Swelling and tenderness of the joint
3. Physical function on day 6 compared to baseline
4. Overall assessment of the success of treatment by patients
5. Most severe pain in the last 24 hours
6. Frequency of use of additional pain medication per treatment group
7. Frequency of use of non-drug pain therapies in the treatment groups

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsmedizin Greifswald KöR

Sponsor organisation

Universitaetsmedizin Greifswald KöR

Address

Ferdinand-Sauerbruch-Strasse

City

Greifswald

Postcode

17489

Country

Germany

Scientific contact point

Organisation

Universitaetsmedizin Greifswald KöR

Contact name

Koordinierungszentrum Klinische Studien

Public contact point

Organisation

Universitaetsmedizin Greifswald KöR

Contact name

Koordinierungszentrum Klinische Studien

Locations

1 EU/EEA country · 68 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications