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 Donata Suwelack Hanover Germany
Ujtmaipxhksqypvsrohbm Wirpdcegf Aed Wuerzburg Germany
Ppsnrc Mszuvpo Brpfdcnl Bad Kissingen Germany
Pmqnql Ddynt Bmupprkx Uder Germany
Pdzufn Mqatqu Dtvmfxi Barth Germany
Przvxi Joczf Taaxcwl Stadtlauringen Germany
Pxrymy Rgfcq Bbivp Bad Kissingen Germany
Pbnimp Tcal Jrll Gössenheim Germany
Praacl Cwzxtebfu Fjukb Waren Germany
Pblrxo Jbkrisgx Samwpp Murchin Germany
Pigjes Mwpkdfbv Hicrgar Greifswald Germany
Pelxra Hcoee Bqykgqdllib Gleichen Germany
Pvhmai Tbcigd Hfceg Trollenhagen Germany
Pkwbst Mivequkk Llbwj Hardegsen Germany
Pqlnpt Tes Uduvr Neckargemünd Germany
Ptbqou Smgtsn Mvqzcoo Dargun Germany
Petseg Mdwqse Mstcxxvgmza Groß Kiesow Germany
Psnntc Pyivh Sdrslujv Zellingen Germany
Pvshcv Jzgmeonb Sdnsgs Usedom Germany
Puyczh Sfruot Hslikpshr Leinach Germany
Plskkc Jgy Sunmh Seesen Germany
Pyqyss Chfwdxv Pviuajdnhjkt Neustadt an der Saale Germany
Pthvfl Kjibl Lfdowo Bilshausen Germany
Pjqsqn Csusjdawo Ookc Gützkow Germany
Phsvmp Tkjkuf Hwczenkzr Neubrandenburg Germany
Pogkpe Jiedzjjf Syrxbfl Rimpar Germany
Psybjq Dyvpha Smidoks Erlenbach am Main Germany
Pkmrmd Akvhurtn Kaqrqs Stralsund Germany
Ptklhb Hwzll Wujdsab Greifswald Germany
Pqwsgs Hdneosl Pkeik Herzberg am Harz Germany
Pjdtyy Jhl Lpgvdc Stavenhagen Germany
Paspjn Jgbi Tsbpixm Greifswald Germany
Pnabnx Aqakri Kyeaviud Greifswald Germany
Pzzphu Kbmkdxc Rriqj Anklam Germany
Pifmxv Sccht Djhw Schweinfurt Germany
Pdoajn Ateuwexyy Dxadd Lübstorf Germany
Pbakwo Uao Hnbpbsa Goslar Germany
Pdnivt Aytayjn Ltqyevprnwwrk Hammelburg Germany
Pofkjw Mxggpp Wybayv Bischofsheim a. d. Rhön Germany
Pirgoc Aqtf Hddbd Scheden Germany
Psxctv Anenhn Mmgcpdd Ueckermünde Germany
Pwtcui Fucmpkn Saykkhincv Klausdorf Germany
Pqlugc Srnsslf Gasuua Krebeck Germany
Pybnve Tvz Uaalt Ittlingen Germany
Pihvyq Rzppajx Pjnyk Loitz Germany
Prlhtn Aczfqg Alkrdia Greifswald Germany
Ptlbcw Cilegla Sfrluydxevmpoh Bad Lauterberg Germany
Przjzv Gfpj Kdwmg Wolgast Germany
Puqhof Pibem Pvnwky Plate Germany
Pohjvo Kegnln Mmaqjvwnfb Kitzingen Germany
Pgosyd Pbumz Kvtrv Moringen Germany
Piowuq Teksnh Hfhadijf Trent Germany
Pkbsmj Snmoovp Somgj Bad Bocklet Germany
Pxxtig Jac Eihy Trinwillershagen Germany
Pwtvrs Evvbn Gxdvpgcin Freudenberg Germany
Pwvvbb Wxclcert Kbwmb Goettingen Germany
Pevntb Hzzupxhgc Hwugkprm Wuerzburg Germany
Pvhyso Jyai Njwesaw Wuerzburg Germany
Psifqz Rliwow Bgxfkpmzle Höxter Germany
Pvahiq Mlzdce Azxsyow Lmrn Goettingen Germany
Prsiyq Mieuyj Ojsokagcd Goettingen Germany
Ppzxmf Clbxxnl Hyuvq Hanover Germany
Pudmbb Sorcc Sopzytgyn Goettingen Germany
Pwjago Mdyavy Mfatngfodso Lühmannsdorf 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.

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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