Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Prednisolone Versus Colchicine for Acute Gout in Primary Care

Q: Who can participate in NCT05698680?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT05698680?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Prednisolone Versus Colchicine for Acute Gout in Primary Care (NCT05698680) is a Phase 4 interventional studying Acute Gout, sponsored by University Medicine Greifswald. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 314 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Prednisolone 30 mg Tablet

See treatment arm "Prednisolone"

DRUG

Colchicine 0.5 mg Oral Tablet

See treatment arm "Colchicine"

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Arztpraxis Burgtorstr. 2

Ittlingen, Baden-Wurttemberg, Germany

Hausarztpraxis Neckarsteinacher Str. 22

Neckargemünd, Baden-Wurttemberg, Germany

Hausarztpraxis Kleinfeldlein 3

Bad Bocklet, Bavaria, Germany

Hausarztpraxis Kapellenstraße 3

Bad Kissingen, Bavaria, Germany

Hausarztpraxis Ludwigstraße 18

Bad Kissingen, Bavaria, Germany

Hausarztpraxis Goethestraße 15 G

Bad Neustadt an der Saale, Bavaria, Germany

Hausarztpraxis Ahornstraße 1

Bischofsheim, Bavaria, Germany

Hausarztpraxis Mechenharder Straße 174

Erlenbach am Main, Bavaria, Germany

Hausarztpraxis Hauptstraße 12

Gössenheim, Bavaria, Germany

Hausarztpraxis Bahnhofstraße 24

Hammelburg, Bavaria, Germany

Hausarztpraxis Torgraben 3

Haßfurt, Bavaria, Germany

Hausarztpraxis Kaiserstraße 43

Kitzingen, Bavaria, Germany

Hausarztpraxis Rathausstraße 31

Leinach, Bavaria, Germany

Hausarztpraxis Herrngasse 11 A

Rimpar, Bavaria, Germany

Hausarztpraxis Spitalstr. 9

Schweinfurt, Bavaria, Germany

Hausarztpraxis Sulzdorfer Straße 6a

Stadtlauringen, Bavaria, Germany

Hausarztpraxis Dorfgraben 2a

Würzburg, Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Hausarztpraxis Moltkestraße 5

Würzburg, Bavaria, Germany

Hausarztpraxis Point 3

Zellingen, Bavaria, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05698680), the sponsor (University Medicine Greifswald), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05698680 clinical trial studying?

Who can participate in NCT05698680?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05698680?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05698680. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05698680. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.