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Acute GoutPhase 4COPAGONCT05698680

Prednisolone Versus Colchicine for Acute Gout in Primary Care

A Phase 4 study testing Prednisolone 30 mg Tablet and Colchicine 0.5 mg Oral Tablet in people with Acute Gout, run by University Medicine Greifswald at 65 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribed for pain relief during an acute gout attack. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Gout
What is being tested?
Prednisolone 30 mg Tablet and Colchicine 0.5 mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
65 sitesGermany
Study dates
18 Jan 2023to 28 Feb 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients ≥ 18 years of age
  • Clinical diagnosis of acute attack of gout (symptoms: pain, swelling, tenderness, redness or local hyperthermia).
  • Acute pain in hand or foot (podagra, chiragra)
  • The onset of pain was no more than 2 days ago (e.g., presentation on Monday afternoon, onset of pain on Saturday morning)
  • Willingness to participate in the study and ability to give written informed consent.

Who cannot join

  • Known intolerance or contraindication to either medication
  • Known intolerance to the placebo (e.g. lactose intolerance).
  • Existing (or less than 2 weeks ago) oral treatment with corticosteroids or colchicine.
  • Known chronic kidney disease (CKD stage 4 or greater) or an available value of estimated glomerular filtration rate (eGFR) < 30ml/min/1.73 m².
  • Known haematopoietic disorder or available values of platelets < 30,000 µl or leucocytes < 4000 µl, or Hb <5 mmol/l/ or 8 g/dl
  • Uncontrolled high blood pressure (systolic blood pressure permanently above 160 mmHg).
Show all 15Show fewer
  • Known liver cirrhosis or severe liver disease or available liver enzymes results (ie. Serum Glutamate Oxalate Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase(SGPT)) being elevated 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
  • Known HIV infection
  • Solid organ transplant with immune suppression
  • Desire to have children within the next 6 months in both men and women
  • Existing pregnancy or breastfeeding
  • Participation in other studies according to the German Medicines Act in the last 3 months
  • Participation in the COPAGO study with past gout attack

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

Germany65 sites

  • Hausarztpraxis Bluthsluster Straße 2

    Anklam, Mecklenburg-Vorpommern, 17389

  • Hausarztpraxis Kleinfeldlein 3

    Bad Bocklet, Bavaria, 97708

  • Hausarztpraxis Kapellenstraße 3

    Bad Kissingen, Bavaria, 97688

  • Hausarztpraxis Ludwigstraße 18

    Bad Kissingen, Bavaria, 97688

  • Hausarztpraxis Wissmannstraße 14

    Bad Lauterberg im Harz, Lower Saxony, 37431

  • Hausarztpraxis Goethestraße 15 G

    Bad Neustadt an der Saale, Bavaria, 97616

  • Hausarztpraxis Am Westhafen 1

    Barth, Mecklenburg-Vorpommern, 18356

  • Hausarztpraxis Hoher Weg 17

    Bilshausen, Lower Saxony, 37343

  • Hausarztpraxis Ahornstraße 1

    Bischofsheim, Bavaria, 97653

  • Hausarztpraxis Schlossstraße 43

    Dargun, Mecklenburg-Vorpommern, 17159

  • Hausarztpraxis Mechenharder Straße 174

    Erlenbach am Main, Bavaria, 63906

  • Hausarztpraxis Bohlendamm 2

    Gleichen, Lower Saxony, 37130

  • Hausarztpraxis Liererstr. 28

    Goslar, Lower Saxony, 38690

  • Hausarztpraxis Hauptstraße 12

    Gössenheim, Bavaria, 97780

  • Universitätsmedizin Göttingen

    Göttingen, Lower Saxony, 37073

  • Hausarztpraxis Ewaldstr. 40a

    Göttingen, Lower Saxony, 37075

  • Hausarztpraxis Hennebergstr. 14a

    Göttingen, Lower Saxony, 37077

  • Hausarztpraxis Backhausstraße 21

    Göttingen, Lower Saxony, 37081

  • Hausarztpraxis Godehardtstraße 26

    Göttingen, Lower Saxony, 37081

  • Krankenhaus Universitätsmedizin Greifswald

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Hausarztpraxis Am Mühlentor 5

    Greifswald, Mecklenburg-Vorpommern, 17489

  • Hausarztpraxis Anklamer Straße 66

    Greifswald, Mecklenburg-Vorpommern, 17489

  • Hausarztpraxis Lange Straße 53

    Greifswald, Mecklenburg-Vorpommern, 17489

  • Hausarztpraxis Markt 1

    Greifswald, Mecklenburg-Vorpommern, 17489

  • Hausarztpraxis Ernst-Thälmann-Ring 66

    Greifswald, Mecklenburg-Vorpommern, 17491

  • Hausarztpraxis Schulstraße 1a

    Groß Kiesow, Mecklenburg-Vorpommern, 17495

  • Hausarztpraxis Pommersche Straße 18

    Gützkow, Mecklenburg-Vorpommern, 17506

  • Hausarztpraxis Bahnhofstraße 24

    Hammelburg, Bavaria, 97762

  • Hausarztpraxis Professor-Eberlein-Str. 6

    Hannoversch Münden, Lower Saxony, 34346

  • Hausarztpraxis Steinstraße 19

    Hannoversch Münden, Lower Saxony, 34346

  • Hausarztpraxis Vor dem Tore 2

    Hardegsen, Lower Saxony, 37181

  • Hausarztpraxis Torgraben 3

    Haßfurt, Bavaria, 97437

  • Hausarztpraxis Eckert Osteroder Str. 9

    Herzberg am Harz, Lower Saxony, 37412

  • Hausarztpraxis Poppe Osteroder Str. 9

    Herzberg am Harz, Lower Saxony, 37412

  • Hausarztpraxis Lambertweg 6

    Höxter, North Rhine-Westphalia, 37671

  • Arztpraxis Burgtorstr. 2

    Ittlingen, Baden-Wurttemberg, 74930

  • Hausarztpraxis Kaiserstraße 43

    Kitzingen, Bavaria, 97318

  • Hausarztpraxis Prohner Straße 43

    Klausdorf, Mecklenburg-Vorpommern, 18445

  • Hausarztpraxis Hauptstraße 34

    Krebeck, Lower Saxony, 37434

  • Hausarztpraxis Rathausstraße 31

    Leinach, Bavaria, 97274

  • Hausarztpraxis August-Levin-Straße 22c

    Loitz, Mecklenburg-Vorpommern, 17121

  • Hausarztpraxis Bahnhofstraße 16

    Lübstorf, Mecklenburg-Vorpommern, 19069

  • Hausarztpraxis Oberreihe 41

    Lühmannsdorf, Mecklenburg-Vorpommern, 17495

  • Hausarztpraxis Neue Straße 22

    Moringen, Lower Saxony, 37186

  • Hausarztpraxis Neckarsteinacher Str. 22

    Neckargemünd, Baden-Wurttemberg, 69151

  • Hausarztpraxis Juri-Gagarin-Ring 24

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

  • Hausarztpraxis Störstraße 2

    Plate, Mecklenburg-Vorpommern, 19086

  • Hausarztpraxis Herrngasse 11 A

    Rimpar, Bavaria, 97222

  • Hausarztpraxis Bahnhofstraße 6

    Scheden, Lower Saxony, 37127

  • Hausarztpraxis Spitalstr. 9

    Schweinfurt, Bavaria, 97241

  • Hausarztpraxis Kampstr. 32

    Seesen, Lower Saxony, 38723

  • Hausarztpraxis Sulzdorfer Straße 6a

    Stadtlauringen, Bavaria, 97488

  • Hausarztpraxis Werdohler Straße 3

    Stavenhagen, Mecklenburg-Vorpommern, 17153

  • Hausarztpraxis Marienstraße 2-4

    Stralsund, Mecklenburg-Vorpommern, 18439

  • Hausarztpraxis Dorfstraße 57

    Trent, Mecklenburg-Vorpommern, 18569

  • Hausarztpraxis Birkenweg 5

    Trinwillershagen, Mecklenburg-Vorpommern, 18320

  • Hausarztpraxis Otto-Lilienthal-Straße 3

    Trollenhagen, Mecklenburg-Vorpommern, 17039

  • Hausarztpraxis Straße der Einheit 56

    Uder, Thuringia, 37318

  • Hausarztpraxis Ueckerstraße 48

    Ueckermünde, Mecklenburg-Vorpommern, 17373

  • Hausarztpraxis Lange Straße 55

    Waren, Mecklenburg-Vorpommern, 17192

  • Hausarztpraxis Wilhelmstraße 3

    Wolgast, Mecklenburg-Vorpommern, 17438

  • Hausarztpraxis Dorfgraben 2a

    Würzburg, Bavaria, 97076

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

  • Hausarztpraxis Moltkestraße 5

    Würzburg, Bavaria, 97082

  • Hausarztpraxis Point 3

    Zellingen, Bavaria, 97225

Other trials in Germany

About this study

Official title: Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care

Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribed for pain relief during an acute gout attack. However to date, no direct comparison of efficacy of colchicine and prednisolone for the treatment of acute gout attacks has been investigated. Furthermore, majority of previous research studies were not only conducted in tertiary centres but also excluded patients with common comorbidities due to contraindications with naproxen.

This pragmatic, prospective, double-blind, parallel-group, randomized, non-inferiority trial will investigate whether prednisolone (treatment drug) is comparable or only acceptably worse than treatment with colchicine (comparison drug) in patients presenting with acute gout. Patients presenting with acute gout to their general practitioners in 60 practices across 3 university sites (Greifswald, Göttingen, and Würzburg) will be invited to participate. Patients often excluded by previous studies due to contraindications with naproxen will also be able to participate. The investigators will compare the absolute levels of the most severe pain on day 3 (in the last 24 hours) measured with an 11-item numerical rating scale as the primary endpoint. Day 0 is the day patients take their study medication for the first time. They are then asked to fill out a study diary at the same time each day to quantify their pain. Pain scores will then be used as comparison between the two medications.

Read the detailed description

SCIENTIFIC BACKGROUND:

Gout is one of the most common rheumatic diseases, affecting 3-6% of men and 1-2% of women in western countries. Due to the severe pain and impaired quality of life, the individual burden of disease during an acute gout attack is very high. Currently, there are several approved medications available for the treatment of acute gout attacks. The EULAR (European League Against Rheumatism) guideline recommends colchicine as the drug of first choice for acute gout attacks. But according to it, non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids can also be used. In contrast, DEGAM (German Society for General Medicine and Family Medicine) recommends using prednisolone.

Most commonly, gout attacks are treated in general practices. However, studies on the treatment of acute gout attacks have so far been conducted mainly in specialised centres, and thus in a selective patient group. The gold standard for the diagnosis of gout in rheumatology centres is the detection of monosodium urate crystals in aspirated joint fluid. In primary care, however, the diagnosis of gout is made on the basis of clinical symptoms alone. Because of the risk of injury and infection, joint puncture is not usually performed on patients in a general practice setting.

Prednisolone and low-dose colchicine were selected for the study due to a high prevalence of patients with contraindications to NSAIDs, including, cardiovascular disease, oral anticoagulation, chronic kidney disease or a history of gastrointestinal disease. Approximately 20-30% of patients with gout are poorly suited for NSAID administration and in previous studies, those patients were excluded.

RESEARCH QUESTION:

This non-inferiority trial is going to investigate whether prednisolone (treatment drug) is comparable or only acceptably worse than treatment with colchicine (comparator drug). Both treatments will be compared on the basis of the absolute pain scores achieved on day 3 of follow-up.

Unlike most studies conducted in tertiary care centres, this study is going to be set in primary care. The dosage of the study's medications will be according to the recommendations of the EULAR and DEGAM guidelines. Both drugs are in tablet form. Since a preference of the treating physicians regarding the use of prednisolone or colchicine is suspected, the study will be conducted in a double-blinded manner. Due to the different intake regimen, placebos will be used in addition to the effective medications (double-dummy method).

DUAL ENERGY COMPUTED TOMOGRAPHY:

The dual energy computed tomography (DECT) is able to detect monosodium urate crystals. The amount of monosodium urate crystals in the joint (volume) is an indicator of disease burden and can also be used to make treatment decisions regarding uric acid-lowering therapy (ULT) to avoid the occurrence of potential future gout attacks. Although imaging techniques, such as DECT, show promise in classifying symptomatic gout, studies to date are small and mainly involve people with long-standing, established disease from a hospital setting. In those with the first acute gout attack, diagnostic sensitivity ranges from 35.7 % to 61.5 %.

Due to the unclear diagnostic sensitivity in first attacks, the DECT examination will not be mandatory in the present study. It will be offered to all participants as optional. About 10% of the participants are expected to have a gout attack in the hand. Since the joints of the feet are the main site of manifestation of acute gout attacks, crystal deposits in the feet are also expected in these study participants. In order to ensure comparability of the volume measurement, the dual energy CT examination is therefore limited to the feet.

The aim of the dual energy CT examination is to describe the frequency and volume of monosodium urate crystals in patients with gout in primary care. In a sensitivity analysis, the primary endpoint in patients with positive DECT findings will be analysed. Furthermore, the association between the duration of gout diagnosis and crystal volume as a marker for disease burden will be investigated. The investigation of the frequency and volume of monosodium urate crystals provides the basis for the design of further studies on the usefulness of DECT for the indication and monitoring of uric acid-lowering therapies in primary care.

STUDY PROCEDURE:

During the study, the participants will attend their General Practitioner's practice twice (baseline and one-off on day 6-8), as well as, an optional visit for a DECT at the university medical centre in the local region (Greifswald or Göttingen; day 7-13) and a one-off telephone interview on day 27-34. The study period for the individual participant will be 4 weeks.

On day 0 (day of first presentation at the general practice), patients with an acute gout attack in the hand or foot present to their general practitioner. If the diagnosis of gout is confirmed and patients are eligible for participation in the study, they will be consented and randomly assigned to one of two treatment groups. While patient group 1 is treated with prednisolone for 5 days, patient group 2 receives colchicine for 5 days. So that neither the patient nor the general practitioner knows the allocation, both treatment groups also receive a placebo (dummy medication). A laboratory test will also be performed to determine serum uric acid levels, as well as, inflammatory markers and renal function. The aim of blood collection and determination of laboratory parameters is to descriptively describe the patient population and to perform subgroup analyses with regard to the primary endpoint.

During days 1 to 6, patients are requested to complete a patient diary. The primary and secondary endpoints (pain, joint swelling, joint tenderness) and, if further analgesia is needed, the use of additional pain medication will be recorded in the diary. Participants who have a blood pressure monitor will be asked to measure and record their blood pressure daily. On day 6, the patients are also asked to assess potential functional limitations caused by the gout attack and to give a global assessment of the treatment success.

After one week, patients return for their follow-up visit (visit 2) to their general practitioners. They are examined again and are asked to return their study diary and any remaining medication packets.

After 4 weeks, the patients will be contacted by telephone by our study nurses and asked about the clinical course of their gout attack (recurrence of an acute gout attack, further treatment, duration of incapacity to work, adverse events). The telephone call lasts about 15 minutes.

In addition, study participants will receive the optional offer to have a one-time dual-energy CT examination of their feet on days 7-13 to check for the presence of uric acid crystals. Imaging of both feet using a Siemens Dual Source SOMATOM Definition Flash or SOMATOM Force will be performed.

Conditions
Acute Gout
Being tested
Prednisolone 30 mg Tablet, Colchicine 0.5 mg Oral Tablet
Keywords
Primary care, Prednisolone, Colchicine, Pragmatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prednisolone 30 mg TabletDrug

    Also called + Placebo

    See treatment arm "Prednisolone"

  • Colchicine 0.5 mg Oral TabletDrug

    Also called + Placebo

    See treatment arm "Colchicine"

Study groups in NCT05698680
Study groupRoleWhat they receive
Prednisolone 30mg (Day 0-4)ExperimentalAs both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the prednisolone arm will receive prednisolone plus a colchicine placebo. The prednisolone placebos contain a bittering agent due to the bitter taste of prednisolone to ensure a similar taste. The dosage is according to EULAR guideline and also within the recommended range of the DEGAM guideline. The cumulative total dose taken per participant within the clinical trial is 150 mg for prednisolone.
Receives: Drug: Prednisolone 30 mg Tablet
Colchicine 1.5 mg (Day 0), 1.0 mg (Day 1-4)Active comparatorAs both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the colchicine arm will receive colchicine plus prednisolone placebo. The dosage is according to EULAR guideline and also within the recommended range of the DEGAM guideline. The cumulative total dose taken per participant within the clinical trial is 5.5mg for colchicine.
Receives: Drug: Colchicine 0.5 mg Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Most severe pain in the last 24 hours

    To investigate whether the efficacy of prednisolone in General Practitioner's care is equally good or only marginally weaker than treatment with low-dose colchicine, the most severe pain in the last 24 hours on day 3 after baseline on an 11-point numerical rating scale is used and compared across groups. The study participants take their study medication for the first time on day 0 and are then asked to fill out their diary daily at the same time to quantify their pain. 0 stands for no pain and 10 for the strongest pain imaginable.

    Measured: Day 3

Secondary outcomes (7)

  1. Average response to treatment

    For this purpose, the most severe pain described on an 11-point numerical rating scale across treatment days (from day 1 - 6 of follow-up) is used and compared across groups. The study participants take their study medication for the first time on day 0 and are then asked to fill out their diary daily at the same time to quantify their pain. 0 stands for no pain and 10 for the strongest pain imaginable.

    Measured: Day 1, 2, 3, 4, 5, 6

  2. Swelling and tenderness of the joint

    Reduction in joint swelling and tenderness measured using 4-point Likert scale on day 3 after baseline per treatment arm, e.g.:

    • Swelling quantified as no joint swelling, palpable, visible, and bulging beyond the joint margins.
    • Sensitivity to touch of the joint is quantified as no pain, pain, pain and winces, and pain, winces and withdraws, and subsequent comparison.

    Measured: Day 3

  3. Physical function

    Physical function on day 6 compared to baseline will be assessed with the following questions:

    • How much are you now restricted in your normal daily activities by the gout attack?
    • How much trouble do you have putting on a shoe today?
    • How much pain do you have when you walk today?
    • How much trouble do you have grasping and holding something with your affected hand (for example, when unscrewing a bottle)?

    All questions will be described on an 11-point numerical rating scale, 0 indicating "not at all/no problem" and 10 indicating "worst pain ever".

    Measured: Day 1 and 6

  4. Patients' global assessment of treatment success

    This is going to be measured measured with 5-point Likert scale (excellent, very good, good, fair, poor) on day 6 after baseline and treatment arms will be compared.

    Measured: Day 6

  5. Most severe pain in the last 24 hours depending on disease duration

    For this outcome the same model specification as for the primary outcome is applied and the adjustment for age will be substituted with adjustment for disease duration.

    Measured: Day 1 and 6

  6. Frequency of use of additional pain medication by treatment group

    The frequency of use of additional pain medication per treatment group will be compared.

    Measured: Day 1 - 6

  7. Frequency of use of non-pharmacological pain therapies

    The frequency of use of non-pharmacological pain therapies per treatment group will be compared.

    Measured: Day 1 - 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start18 Jan 2023
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Why it stopped: The study was terminated due to an inability to reach the planned sample size, despite efforts to enhance recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This clinical trial is a two-arm multicentre, pragmatic, prospective, randomised, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design (phase IV). According to the guidelines of the German Society of General Medicine (DEGAM), the decision to start gout treatment is made clinically. As this is a pragmatic study, eligibility will be determined during a routine clinical examination. The clinical diagnosis is made without new laboratory tests, joint puncture with synovial analysis or imaging. 314 patients with an acute gout attack are going to be recruited in 60 General Practitioner's practices across 3 university sites (Greifswald, Göttingen, and Würzburg). All study participants receive active treatments, but are randomised into either the prednisolone group (treatment group) or the colchicine group (comparison group). The study lasts 4 weeks for each participant.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698680
Sponsor's protocol ID
202102COPAGO
Other IDs
01KG2022, 2024-514738-18-00, 2021-005556-11
Acronym
COPAGO
Status last verified
May 2026
First submitted
27 Dec 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Original data of the analyses will be made available for re-use.

Publications

  • Richter A, Truthmann J, Hummers E, Pereira JFM, Gagyor I, Schuster F, Witte A, Bohm S, Greser A, Kamin P, Stracke S, Dorr M, Bulow R, Engeli S, Chenot JF, Ittermann T. Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial. Trials. 2024 Apr 3;25(1):229. doi: 10.1186/s13063-024-08066-0.

    PubMed 38570873

  • Truthmann J, Freyer Martins Pereira J, Richter A, Schuster F, Witte A, Bohm S, Greser A, Kamin P, Stracke S, Dorr M, Bulow R, Engeli S, Gagyor I, Hummers E, Chenot JF. Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO): protocol for a two-arm multicentre, pragmatic, prospective, randomized, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design. Trials. 2023 Oct 5;24(1):643. doi: 10.1186/s13063-023-07666-6.

    PubMed 37798801

  • Dalbeth N, Merriman TR, Stamp LK. Gout. Lancet. 2016 Oct 22;388(10055):2039-2052. doi: 10.1016/S0140-6736(16)00346-9. Epub 2016 Apr 21.

    PubMed 27112094

  • Campion EW, Glynn RJ, DeLabry LO. Asymptomatic hyperuricemia. Risks and consequences in the Normative Aging Study. Am J Med. 1987 Mar;82(3):421-6. doi: 10.1016/0002-9343(87)90441-4.

    PubMed 3826098

  • Fisher MC, Rai SK, Lu N, Zhang Y, Choi HK. The unclosing premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017 Jul;76(7):1289-1294. doi: 10.1136/annrheumdis-2016-210588. Epub 2017 Jan 25.

    PubMed 28122760

  • ten Klooster PM, Vonkeman HE, Voshaar MA, Bode C, van de Laar MA. Experiences of gout-related disability from the patients' perspective: a mixed methods study. Clin Rheumatol. 2014 Aug;33(8):1145-54. doi: 10.1007/s10067-013-2400-6.

    PubMed 24077900

  • Richette P, Doherty M, Pascual E, Barskova V, Becce F, Castaneda-Sanabria J, Coyfish M, Guillo S, Jansen TL, Janssens H, Liote F, Mallen C, Nuki G, Perez-Ruiz F, Pimentao J, Punzi L, Pywell T, So A, Tausche AK, Uhlig T, Zavada J, Zhang W, Tubach F, Bardin T. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017 Jan;76(1):29-42. doi: 10.1136/annrheumdis-2016-209707. Epub 2016 Jul 25.

    PubMed 27457514

  • van Echteld I, Wechalekar MD, Schlesinger N, Buchbinder R, Aletaha D. Colchicine for acute gout. Cochrane Database Syst Rev. 2014 Aug 15;(8):CD006190. doi: 10.1002/14651858.CD006190.pub2.

    PubMed 25123076

  • Finkelstein Y, Aks SE, Hutson JR, Juurlink DN, Nguyen P, Dubnov-Raz G, Pollak U, Koren G, Bentur Y. Colchicine poisoning: the dark side of an ancient drug. Clin Toxicol (Phila). 2010 Jun;48(5):407-14. doi: 10.3109/15563650.2010.495348.

    PubMed 20586571

  • Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. High versus low dosing of oral colchicine for early acute gout flare: Twenty-four-hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study. Arthritis Rheum. 2010 Apr;62(4):1060-8. doi: 10.1002/art.27327.

    PubMed 20131255

  • Engel B, Prautzsch H. [Acute gout in primary care]. 2013. Available from: https://www.awmf.org/uploads/tx_szleitlinien/053_032bl_S1_akute_Gicht_2014-05.pdf

  • van Durme CM, Wechalekar MD, Buchbinder R, Schlesinger N, van der Heijde D, Landewe RB. Non-steroidal anti-inflammatory drugs for acute gout. Cochrane Database Syst Rev. 2014 Sep 16;(9):CD010120. doi: 10.1002/14651858.CD010120.pub2.

    PubMed 25225849

  • Janssens HJ, Janssen M, van de Lisdonk EH, van Riel PL, van Weel C. Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial. Lancet. 2008 May 31;371(9627):1854-60. doi: 10.1016/S0140-6736(08)60799-0.

    PubMed 18514729

  • McKenzie BJ, Wechalekar MD, Johnston RV, Schlesinger N, Buchbinder R. Colchicine for acute gout. Cochrane Database Syst Rev. 2021 Aug 26;8(8):CD006190. doi: 10.1002/14651858.CD006190.pub3.

    PubMed 34438469

  • Janssens HJEM, Fransen J, Janssen M, Neogi T, Schumacher HR, Jansen TL, Dalbeth N, Taylor WJ. Performance of the 2015 ACR-EULAR classification criteria for gout in a primary care population presenting with monoarthritis. Rheumatology (Oxford). 2017 Aug 1;56(8):1335-1341. doi: 10.1093/rheumatology/kex164.

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Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prednisolone 30 mg Tablet and Colchicine 0.5 mg Oral Tablet in people with Acute Gout, run by University Medicine Greifswald at 65 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to an inability to reach the planned sample size, despite efforts to enhance recruitment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Most severe pain in the last 24 hours (time frame: Day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05698680, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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