Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO)

February 6, 2024 updated by: University Medicine Greifswald

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

314

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden-Württemberg
      • Igersheim, Baden-Württemberg, Germany, 97999
        • Recruiting
        • Hausarztpraxis Schulstraße 4
        • Contact:
          • Christian Kipp, Dr. med.
          • Phone Number: 5403100 0049 7931
      • Ittlingen, Baden-Württemberg, Germany, 74930
        • Recruiting
        • Arztpraxis Burgtorstr. 2
        • Contact:
          • Til Uebel, Dr. med.
      • Neckargemünd, Baden-Württemberg, Germany, 69151
        • Recruiting
        • Hausarztpraxis Neckarsteinacher Str. 22
        • Contact:
          • Til Uebel, Dr. med.
          • Phone Number: 867188 0049 6223
    • Bayern
      • Bad Bocklet, Bayern, Germany, 97708
        • Recruiting
        • Hausarztpraxis Kleinfeldlein 3
        • Contact:
          • Stephan Stoll, Dr. med.
          • Phone Number: 704310 0049 9708
      • Bad Kissingen, Bayern, Germany, 97688
        • Recruiting
        • Hausarztpraxis Kapellenstraße 3
        • Contact:
          • Michael Brendler
          • Phone Number: 5169 0049 971
      • Bad Kissingen, Bayern, Germany, 97688
        • Recruiting
        • Hausarztpraxis Ludwigstraße 18
        • Contact:
          • Ralph Brath, Dr. med.
          • Phone Number: 4235 0049 971
      • Bad Neustadt An Der Saale, Bayern, Germany, 97616
        • Recruiting
        • Hausarztpraxis Goethestraße 15 G
        • Contact:
          • Claudia Pladek-Weier
          • Phone Number: 4099 0049 9771
      • Bad Neustadt An Der Saale, Bayern, Germany, 97616
        • Recruiting
        • Hausarztpraxis Rhönstraße 11
        • Contact:
          • Torsten Zauper, Dr. rer. nat.
          • Phone Number: 3246 0049 9771
      • Bischofsheim, Bayern, Germany, 97653
        • Recruiting
        • Hausarztpraxis Ahornstraße 1
        • Contact:
          • Martin Wünsch, Dr. med.
          • Phone Number: 257 0049 9772
      • Erlenbach am Main, Bayern, Germany, 63906
        • Recruiting
        • Hausarztpraxis Mechenharder Straße 174
        • Contact:
          • Detlef Schmitz, Dr. med.
          • Phone Number: 944860 0049 9372
      • Hammelburg, Bayern, Germany, 97762
        • Recruiting
        • Hausarztpraxis Bahnhofstraße 24
        • Contact:
          • Andreas Langeheinecke, Dr. med.
          • Phone Number: 783190 0049 9732
      • Haßfurt, Bayern, Germany, 97437
        • Recruiting
        • Hausarztpraxis Torgraben 3
        • Contact:
          • Carolin Fritzenkötter, Dr. med.
          • Phone Number: 1504 0049 9521
      • Kitzingen, Bayern, Germany, 97318
        • Recruiting
        • Hausarztpraxis Kaiserstraße 43
        • Contact:
          • Konrad Mittenzwei
          • Phone Number: 4700 0049 9321
      • Rimpar, Bayern, Germany, 97222
        • Recruiting
        • Hausarztpraxis Herrngasse 11 A
        • Contact:
          • Johannes Schmitt
          • Phone Number: 80870 0049 9365
      • Schweinfurt, Bayern, Germany, 97241
        • Recruiting
        • Hausarztpraxis Spitalstr. 9
        • Contact:
          • Silke Daci
          • Phone Number: 25151 0049 9721
      • Stadtlauringen, Bayern, Germany, 97488
        • Recruiting
        • Hausarztpraxis Sulzdorfer Straße 6a
        • Contact:
          • Julia Treiber, Dr. med.
          • Phone Number: 543 0049 9724
      • Würzburg, Bayern, Germany, 97080
        • Recruiting
        • Universitätsklinikum Würzburg
        • Contact:
          • Ildikó Gágyor, Prof. Dr. med.
          • Phone Number: 20147802 0049 931
          • Email: gagyor_i@ukw.de
      • Würzburg, Bayern, Germany, 97076
        • Recruiting
        • Hausarztpraxis Dorfgraben 2a
        • Contact:
          • Hans-Jörg Hellmuth, Dr. med.
          • Phone Number: 272562 0049 921
      • Würzburg, Bayern, Germany, 97082
        • Recruiting
        • Hausarztpraxis Moltkestraße 5
        • Contact:
          • Nandini Jain, Dr. med.
          • Phone Number: 45258805 0049 931
      • Zellingen, Bayern, Germany, 97225
        • Recruiting
        • Hausarztpraxis Point 3
        • Contact:
          • Petra Schlegel, Dr. med.
          • Phone Number: 5884 0049 9364
    • Mecklenburg-Vorpommern
      • Anklam, Mecklenburg-Vorpommern, Germany, 17389
        • Recruiting
        • Hausarztpraxis Bluthsluster Straße 2
        • Contact:
          • Kristin Runge, Dr. med.
          • Phone Number: 212323 0049 3971
      • Dargun, Mecklenburg-Vorpommern, Germany, 17159
        • Recruiting
        • Hausarztpraxis Schlossstraße 43
        • Contact:
          • Mahmoud Sannan
          • Phone Number: 20040 0049 39959
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
        • Recruiting
        • Hausarztpraxis Am Mühlentor 5
        • Contact:
          • Matthias Herberg, Dr. med.
          • Phone Number: 2373 0049 3834
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
        • Recruiting
        • Hausarztpraxis Anklamer Straße 66
        • Contact:
          • Jens Thonack, Prof. Dr. med.
          • Phone Number: 814167 0049 3834
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
        • Recruiting
        • Hausarztpraxis Lange Straße 53
        • Contact:
          • Hanna Wilfert, Dr. med.
          • Phone Number: 2718 0049 3834
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
        • Recruiting
        • Hausarztpraxis Markt 1
        • Contact:
          • Annika Kohlhase, Dr. med.
          • Phone Number: 2976 0049 3834
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17491
        • Recruiting
        • Hausarztpraxis Ernst-Thälmann-Ring 66
        • Contact:
          • Aniela Angelow, Dr. med.
          • Phone Number: 885765 0049 3834
      • Groß Kiesow, Mecklenburg-Vorpommern, Germany, 17495
        • Recruiting
        • Hausarztpraxis Schulstraße 1a
        • Contact:
          • Mirjam Mittelstädt
          • Phone Number: 307 0049 38356
      • Gützkow, Mecklenburg-Vorpommern, Germany, 17506
        • Recruiting
        • Hausarztpraxis Pommersche Straße 18
        • Contact:
          • Christian Ottl, Dr. med.
          • Phone Number: 714371 0049 38353
      • Loitz, Mecklenburg-Vorpommern, Germany, 17121
        • Recruiting
        • Hausarztpraxis August-Levin-Straße 22c
        • Contact:
          • Rebekka Preuß, Dr. med.
          • Phone Number: 10388 0049 39998
      • Lübstorf, Mecklenburg-Vorpommern, Germany, 19069
        • Recruiting
        • Hausarztpraxis Bahnhofstraße 16
        • Contact:
          • Alexander Dagge, Dr. med.
          • Phone Number: 247 0049 3867
      • Lühmannsdorf, Mecklenburg-Vorpommern, Germany, 17495
        • Recruiting
        • Hausarztpraxis Oberreihe 41
        • Contact:
          • Mirjam Mittelstädt
          • Phone Number: 61273 0049 38355
      • Murchin, Mecklenburg-Vorpommern, Germany, 17390
        • Recruiting
        • Hausarztpraxis Pinnow 41
        • Contact:
          • Johannes Spanke
          • Phone Number: 240303 0049 3971
      • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
        • Recruiting
        • Hausarztpraxis Juri-Gagarin-Ring 24
        • Contact:
          • Thomas Hannemann, Dr. med.
          • Phone Number: 77823230 0049 395
      • Plate, Mecklenburg-Vorpommern, Germany, 19086
        • Recruiting
        • Hausarztpraxis Störstraße 2
        • Contact:
          • Petra Pöhler
          • Phone Number: 3038640 0049 3861
      • Reuterstadt Stavenhagen, Mecklenburg-Vorpommern, Germany, 17153
        • Recruiting
        • Hausarztpraxis Werdohler Straße 3
        • Contact:
          • Jan Lichte, Dr. med.
          • Phone Number: 22695 0049 39954
      • Trinwillershagen, Mecklenburg-Vorpommern, Germany, 18320
        • Recruiting
        • Hausarztpraxis Birkenweg 5
        • Contact:
          • Jan Eska, Dr. med.
          • Phone Number: 51818 0049 38225
      • Trollenhagen, Mecklenburg-Vorpommern, Germany, 17039
        • Recruiting
        • Hausarztpraxis Otto-Lilienthal-Straße 3
        • Contact:
          • Thomas Hanff
          • Phone Number: 45506780 0049 395
      • Ueckermünde, Mecklenburg-Vorpommern, Germany, 17373
        • Recruiting
        • Hausarztpraxis Ueckerstraße 48
        • Contact:
          • Andrea Mossner, Dr. med.
          • Phone Number: 54230 0049 39771
      • Usedom, Mecklenburg-Vorpommern, Germany, 17406
        • Recruiting
        • Hausarztpraxis Markt 3
        • Contact:
          • Johannes Spanke
          • Phone Number: 779880 0049 38372
      • Waren, Mecklenburg-Vorpommern, Germany, 17192
        • Recruiting
        • Hausarztpraxis Lange Straße 55
        • Contact:
          • Christian Flamm, Dr. med.
          • Phone Number: 666009 0049 3991
      • Wolgast, Mecklenburg-Vorpommern, Germany, 17438
        • Recruiting
        • Hausarztpraxis Wilhelmstraße 3
        • Contact:
          • Gero Kärst, Dr. med.
          • Phone Number: 202384 0049 3836
    • Niedersachsen
      • Bad Lauterberg Im Harz, Niedersachsen, Germany, 37431
        • Recruiting
        • Hausarztpraxis Wissmannstraße 14
        • Contact:
          • Cordula Sachse-Seeboth, Dr. med.
          • Phone Number: 852314 0049 5524
      • Bilshausen, Niedersachsen, Germany, 37343
        • Recruiting
        • Hausarztpraxis Hoher Weg 17
        • Contact:
          • Karen Lodhia, Dr. med.
          • Phone Number: 92380 0049 5528
      • Gleichen, Niedersachsen, Germany, 37130
        • Recruiting
        • Hausarztpraxis Bohlendamm 2
        • Contact:
          • Helia Beulshausen
          • Phone Number: 97780 0049 5508
      • Goslar, Niedersachsen, Germany, 38690
        • Recruiting
        • Hausarztpraxis Liererstr. 28
        • Contact:
          • Ute Heskamp, Dr. med.
          • Phone Number: 2210 0049 5324
      • Göttingen, Niedersachsen, Germany, 37075
        • Recruiting
        • Hausarztpraxis Ewaldstr. 40a
        • Contact:
          • Martin Andreas Lang, Dr. med.
          • Phone Number: 5311333 0049 551
      • Göttingen, Niedersachsen, Germany, 37081
        • Recruiting
        • Hausarztpraxis Godehardtstraße 26
        • Contact:
          • Sarah Schilling, Dr. med.
          • Phone Number: 27071170 0049 551
      • Göttingen, Niedersachsen, Germany, 37073
      • Göttingen, Niedersachsen, Germany, 37077
        • Recruiting
        • Hausarztpraxis Hennebergstr. 14a
        • Contact:
          • Michal Olszewski, Dr. med.
          • Phone Number: 31678 0049 551
      • Göttingen, Niedersachsen, Germany, 37081
        • Recruiting
        • Hausarztpraxis Backhausstraße 21
        • Contact:
          • Wolfgang Keske, Dr. med.
          • Phone Number: 91191 0049 551
      • Hann. Münden, Niedersachsen, Germany, 34346
        • Recruiting
        • Hausarztpraxis Professor-Eberlein-Str. 6
        • Contact:
          • Carsten Hafer, Dr. med.
          • Phone Number: 35055 0049 5541
      • Hann. Münden, Niedersachsen, Germany, 34346
        • Recruiting
        • Hausarztpraxis Steinstraße 19
        • Contact:
          • Donata Suwelack
          • Phone Number: 1043 0049 5545
      • Hardegsen, Niedersachsen, Germany, 37181
        • Recruiting
        • Hausarztpraxis Vor dem Tore 2
        • Contact:
          • Matthias Löber, Dr. med.
          • Phone Number: 5122 0049 5505
      • Herzberg Am Harz, Niedersachsen, Germany, 37412
        • Recruiting
        • Hausarztpraxis Poppe Osteroder Str. 9
        • Contact:
          • Henning Poppe
          • Phone Number: 71047 0049 5521
      • Herzberg am Harz, Niedersachsen, Germany, 37412
        • Recruiting
        • Hausarztpraxis Eckert Osteroder Str. 9
        • Contact:
          • Moritz Eckert
          • Phone Number: 71047 0049 5521
      • Katlenburg-Lindau, Niedersachsen, Germany, 37191
        • Recruiting
        • Hausarztpraxis Im Siek 10
        • Contact:
          • Emine Jacobi
          • Phone Number: 1088 0049 5556
      • Scheden, Niedersachsen, Germany, 37127
        • Recruiting
        • Hausarztpraxis Bahnhofstraße 6
        • Contact:
          • Anne Hafer, Dr. med.
          • Phone Number: 97090 0049 5546
      • Seesen, Niedersachsen, Germany, 38723
        • Recruiting
        • Hausarztpraxis Kampstr. 32
        • Contact:
          • Jan Sturm, Dr. med.
          • Phone Number: 9839898 0049 5381
    • Nordrhein-Westfalen
      • Höxter, Nordrhein-Westfalen, Germany, 37671
        • Recruiting
        • Hausarztpraxis Lambertweg 6
        • Contact:
          • Regina Beverungen, Dr. med.
          • Phone Number: 97400 0049 5271
    • Thüringen
      • Uder, Thüringen, Germany, 37318
        • Recruiting
        • Hausarztpraxis Straße der Einheit 56
        • Contact:
          • David Baudisch
          • Phone Number: 40555 0049 36083

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisolone 30mg (Day 0-4)

As 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.
Drug: Prednisolone 30 mg Tablet
See treatment arm "Prednisolone"
Other Names:
  • + Placebo
Active Comparator: Colchicine 1.5 mg (Day 0), 1.0 mg (Day 1-4)

As 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.
Drug: Colchicine 0.5 mg Oral Tablet
See treatment arm "Colchicine"
Other Names:
  • + Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Most severe pain in the last 24 hours
Time Frame: Day 3
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.
Day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average response to treatment
Time Frame: Day 1, 2, 3, 4, 5, 6
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.
Day 1, 2, 3, 4, 5, 6
Swelling and tenderness of the joint
Time Frame: Day 3

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.
Day 3
Physical function
Time Frame: Day 1 and 6

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".
Day 1 and 6
Patients' global assessment of treatment success
Time Frame: Day 6
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.
Day 6
Most severe pain in the last 24 hours depending on disease duration
Time Frame: Day 1 and 6
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.
Day 1 and 6
Frequency of use of additional pain medication by treatment group
Time Frame: Day 1 - 6
The frequency of use of additional pain medication per treatment group will be compared.
Day 1 - 6
Frequency of use of non-pharmacological pain therapies
Time Frame: Day 1 - 6
The frequency of use of non-pharmacological pain therapies per treatment group will be compared.
Day 1 - 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dual Energy Computed Tomography Investigation: Presence of monosodium urate crystals
Time Frame: one assessment during days 7 - 13
The frequency and volume of monosodium urate crystals (milliliter) in feet joints in patients with gout in primary care will be investigated.
one assessment during days 7 - 13
Dual Energy Computed Tomography Investigation: Patient characteristics
Time Frame: one assessment during days 7 - 13
The investigators will investigate the association between the volume of monosodium urate crystals (milliliter) in feet joints and patient characteristics (e.g. age, sex, previous gout attacks).
one assessment during days 7 - 13
Dual Energy Computed Tomography Investigation: Use of uricostats and uricosurics
Time Frame: one assessment during days 7 - 13
The investigators will investigate the association between frequency and volume of monosodium urate crystals (milliliter) in feet joints in patients with gout in primary care and (previous) use of uricostats and uricosurics.
one assessment during days 7 - 13
Dual Energy Computed Tomography Investigation: Pain intensity
Time Frame: one assessment during days 7 - 13
The investigators will investigate the association between the volume of monosodium urate crystals (milliliter) in feet joints in patients with gout in primary care and pain intensity at baseline (on an 11-point numerical rating scale).
one assessment during days 7 - 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

Wuerzburg University Hospital
University of Göttingen

Investigators

  • Principal Investigator: Sylvia Stracke, University Medicine Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202102COPAGO
  • 2021-005556-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Original data of the analyses will be made available for re-use.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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