Study on Treating Acute Gout Attacks with Prednisolone and Colchicine for Primary Care Patients

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What is this study about?

This clinical trial is focused on studying the treatment of acute gout attacks, a condition characterized by sudden and severe pain in the joints, often affecting the hand or foot. The study compares two treatments: Prednisolone and Colchicine. Prednisolone is a type of medication known as a glucocorticosteroid, which helps reduce inflammation and pain. Colchicine is another medication used to treat gout by reducing swelling and pain.

The purpose of the study is to evaluate the effectiveness of these treatments in managing the most severe pain experienced during an acute gout attack. Participants in the study will receive either Prednisolone, Colchicine, or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers know which treatment each participant is receiving, to ensure unbiased results.

Throughout the study, participants will take the medication orally for a period of up to five days. Researchers will monitor the participants’ pain levels, joint swelling, and overall physical function. The study aims to determine which treatment provides the best relief from pain and improves joint function during an acute gout attack. Participants’ feedback on the success of the treatment and any additional pain relief methods used will also be collected to provide a comprehensive understanding of the treatment’s effectiveness.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 years and over), acute pain in the hand or foot, and a clinical diagnosis of an acute gout attack. The onset of pain must have occurred no more than 2 days ago.

2 randomization

Participants are randomly assigned to one of two treatment groups. This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered to ensure unbiased results.

3 treatment administration

Participants receive either prednisolone or colchicine orally. The specific dosage and frequency are determined by the study protocol, which is not detailed here.

4 monitoring and follow-up

Participants are monitored for their response to treatment from day 1 to day 6. This includes assessing the most severe pain experienced in the last 24 hours, swelling and tenderness of the joint, and physical function on day 6 compared to the baseline.

5 assessment of treatment success

Participants provide an overall assessment of the success of the treatment. The frequency of additional pain medication use and non-drug pain therapies is also recorded.

Who Can Join the Study?

  • Adult patients aged 18 years and over
  • Experiencing acute pain in the hand or foot. Acute pain means sudden and severe pain.
  • The start of the pain was no more than 2 calendar days ago
  • A clinical diagnosis of an acute attack of gout. This means a doctor has confirmed that you have a sudden gout attack.
  • Willingness to participate in the study and ability to give written informed consent. This means you agree to join the study and can sign a form saying you understand what it involves.

Who Cannot Join the Study?

  • Patients who are not experiencing a gout attack cannot participate. A gout attack is a sudden and severe pain in the joints, often in the big toe.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are not experiencing severe pain in the last 24 hours cannot participate. Severe pain is measured on a scale from 0 to 10, where 10 is the worst pain imaginable.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Praxis Carolin Fritzenkötter Haßfurt Germany
University Medicine Greifswald Greifswald Germany
Universitaetsmedizin Goettingen Goettingen Germany

Other Sites

Site Name City Country Status
Praxis Wolfgang Keske Goettingen Germany
Praxis Hans-Jörg Hellmuth Wuerzburg Germany
Praxis Donata Suwelack Hanover Germany
Praxis Jain Nandini Wuerzburg Germany
Praxis Regina Beverungen Höxter Germany
Praxis Martin Andreas Lang Goettingen Germany
Praxis Michal Olszewski Goettingen Germany
Praxis Carsten Hafer Hanover Germany
Praxis Sarah Schilling Goettingen Germany
Pacpqp Mnkbtxk Biqatwpk Bad Kissingen Germany
Pkamxt Dqpnz Bxcxxhyf Uder Germany
Pxgpot Mratpp Dghuazj Barth Germany
Pfocwf Jyudh Tyvjcfv Stadtlauringen Germany
Pyxekq Rgppl Bmxmn Bad Kissingen Germany
Pngkpx Tewk Jnxw Gössenheim Germany
Pkwvpl Cxhpvetdl Fdmsv Waren Germany
Pncajh Jpkrxhmp Sasgur Murchin Germany
Pehaji Mlhsulfi Hboagoz Greifswald Germany
Pzlwnr Heduw Bkqmazkgvma Gleichen Germany
Pesskx Tokilk Hqazm Trollenhagen Germany
Pbkjbs Mbkfjfyi Lobhh Hardegsen Germany
Paygbq Tic Umkeh Neckargemünd Germany
Ppwiva Szhvbt Mhtgysy Dargun Germany
Pedbdz Mjhclg Mktmqryxewl Groß Kiesow Germany
Pgwgrk Puwmz Srtprzvn Zellingen Germany
Ppngjf Jkufefct Sqilvm Usedom Germany
Pxbuvw Srpikw Hxbigdvps Leinach Germany
Pmntmw Jmk Sjmwg Seesen Germany
Psyjub Cwwfxov Phadficbqluh Neustadt an der Saale Germany
Pzwlvo Kjnvo Lafqpf Bilshausen Germany
Pxbect Cvcqbjval Owzr Gützkow Germany
Pkqjnr Tniplh Hwznowrto Neubrandenburg Germany
Ptmcvc Jhmolisr Sgninqn Rimpar Germany
Pqvuqg Dkjurz Sacyqor Erlenbach am Main Germany
Pskvcg Ajgeshjb Kvobme Stralsund Germany
Plekmd Hsvwp Wqlaazu Greifswald Germany
Pzmgno Hexyyey Pcuis Herzberg am Harz Germany
Ptdoee Jvj Lbhode Stavenhagen Germany
Pejtzt Jvrl Tlbiplz Greifswald Germany
Ppyrvn Afetyc Kyjazeml Greifswald Germany
Pvreau Kggjduw Rmqph Anklam Germany
Pkljce Sfkhx Dzcs Schweinfurt Germany
Ppejjj Abpvntyqh Dzdks Lübstorf Germany
Pdaphh Uzd Hqmwdlk Goslar Germany
Pucrlc Alujzih Lvqhcetflfosl Hammelburg Germany
Pbjiwu Mkpvie Wtkyrf Bischofsheim a. d. Rhön Germany
Putykg Arjl Haltu Scheden Germany
Pnasuy Ayazhm Mgrnjyb Ueckermünde Germany
Puftlk Frzbaue Sqmcifpotx Klausdorf Germany
Pjvizp Sfxejvn Gesmko Krebeck Germany
Pgspku Tqi Uituj Ittlingen Germany
Pylzod Rtjcfem Pnrcn Loitz Germany
Pjjury Afjxym Atmvaqm Greifswald Germany
Piafxi Cjtfggs Stluavbztqogcf Bad Lauterberg Germany
Pehkao Gqao Kpitz Wolgast Germany
Pptyfu Pstrd Pircop Plate Germany
Pkpfmz Kbtpkg Muydwamphi Kitzingen Germany
Prwqns Pkjlk Kiodx Moringen Germany
Pqjqpo Tcyscy Hinqprhs Trent Germany
Pevllz Sdzgnpn Ssgdt Bad Bocklet Germany
Pcqdzu Jsz Erlb Trinwillershagen Germany
Pyrhar Egwry Gdeqznvra Freudenberg Germany
Uctxtjsjdlckifcewqxps Weeuzsgug Aac Wuerzburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
18.01.2023

Trial locations

Investigated drugs:

Prednisolone is a medication used in this trial to treat acute gout attacks. It is a type of corticosteroid that helps reduce inflammation and relieve pain. In the context of this study, it is being compared to another treatment to see how effective it is in managing the severe pain associated with gout.

Colchicine is another medication being tested in this trial for the treatment of acute gout attacks. It works by reducing the inflammation caused by gout, which helps to alleviate pain. This study aims to compare its effectiveness against another treatment option to determine the best approach for managing gout pain.

Investigated diseases:

Gout – Gout is a type of arthritis characterized by sudden, severe attacks of pain, redness, and swelling in the joints, often affecting the big toe. It occurs when urate crystals accumulate in the joint, causing inflammation and intense pain. These crystals form when there are high levels of uric acid in the blood. An acute gout attack typically begins at night and can last for several days, with the most severe pain occurring within the first 24 hours. The affected joint becomes hot, swollen, and extremely tender, making movement difficult. Over time, repeated attacks can lead to joint damage and decreased mobility.

Trial ID:
2024-514738-18-00
Protocol code:
202102COPAGO
Trial Phase:
Therapeutic confirmatory (Phase III)

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