Diseases / Gout
Gout
DiseaseGout is an inflammatory arthritis caused by monosodium urate crystal deposition in joints and periarticular tissues due to hyperuricemia. It presents with recurrent attacks of severe joint pain, swelling, redness, and warmth, classically affecting the first metatarsophalangeal joint. Untreated disease may lead to tophi, kidney stones, and chronic joint damage.
- Trials
- 306
- Recruiting
- 27
- Completed
- 195
- With results
- 81
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | — | 3 | 1 | — | — | — | 4 |
| Phase 1 | 4 | — | — | — | 40 | 1 | — | — | 5 | 50 |
| Phase 1/2 | — | — | — | 1 | 4 | 1 | — | — | — | 6 |
| Phase 2 | 4 | 1 | — | 2 | 48 | 2 | 1 | 1 | 1 | 60 |
| Phase 2/3 | 1 | — | — | 1 | 2 | 1 | — | — | — | 5 |
| Phase 3 | 2 | — | — | 2 | 33 | 3 | 1 | — | — | 41 |
| Phase 4 | 6 | 3 | — | — | 19 | 2 | — | — | 1 | 31 |
| Not applicable | 4 | 6 | 1 | 5 | 24 | 3 | 2 | — | 11 | 56 |
| Unknown | 6 | 2 | — | 2 | 22 | — | 3 | 1 | 17 | 53 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Gout | 4 | 50 | 6 | 60 | 5 | 41 | 31 | 56 | 53 | 306 |
| Hyperuricemia | 2 | 25 | 3 | 31 | 2 | 7 | 8 | 10 | 9 | 97 |
| Arthritis | — | — | — | 2 | 1 | 6 | 1 | 8 | 7 | 25 |
| Arthritis, Gouty | — | — | — | 5 | 1 | 5 | 2 | 1 | 3 | 17 |
| Cardiovascular Diseases | 1 | — | — | — | — | — | 1 | 4 | 11 | 17 |
| Arthritis, Rheumatoid | — | — | — | — | — | — | — | 4 | 12 | 16 |
| Diabetes Mellitus | 1 | — | — | — | — | — | 1 | 3 | 11 | 16 |
| Hypertension | — | — | — | — | — | — | 2 | 2 | 10 | 14 |
| Osteoarthritis | 1 | — | — | — | — | — | 2 | 3 | 8 | 14 |
| Obesity | — | — | — | — | — | — | 1 | 3 | 8 | 12 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Ardea Biosciences, Inc. | 20 | 6 |
| 2 | Takeda | 15 | 6 |
| 3 | LG Chem | 10 | 2 |
| 4 | Atom Therapeutics Co., Ltd | 9 | 2 |
| 5 | Novartis Pharmaceuticals | 7 | 6 |
| 6 | Regeneron Pharmaceuticals | 7 | 5 |
| 7 | Amgen | 6 | 0 |
| 8 | Arthrosi Therapeutics | 6 | 2 |
| 9 | Assistance Publique - Hôpitaux de Paris | 6 | 0 |
| 10 | AstraZeneca | 6 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Allopurinol | 45 |
| 2 | Febuxostat | 45 |
| 3 | Colchicine | 27 |
| 4 | lesinurad | 12 |
| 5 | Pegloticase | 12 |
| 6 | verinurad | 11 |
| 7 | Methotrexate | 8 |
| 8 | canakinumab | 7 |
| 9 | Naproxen | 7 |
| 10 | ruzinurad | 7 |
Evidence
- Results reported
- 41.5%81 of 195 completed
- Published
- 12.3%24 of 195 completed
- Primary endpoint met
- 73%84 of 115 analyses
- Median months to report
- 18
Documents disclosed
Trial profile
- Median enrollment
- 84
- Median duration
- 20months
- Countries
- 54
- Study sites
- 2699
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 30
- Phase 1
- 29
- Phase 1/2
- 48
- Phase 2
- 84
- Phase 2/3
- 300
- Phase 3
- 397
- Phase 4
- 74
- Not applicable
- 76
- Unknown
- 210
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Birmingham | United States | 45 |
| 2 | Duncansville | United States | 41 |
| 3 | Tampa | United States | 39 |
| 4 | San Antonio | United States | 37 |
| 5 | Dallas | United States | 36 |
| 6 | Miami | United States | 36 |
| 7 | Houston | United States | 34 |
| 8 | Cincinnati | United States | 26 |
| 9 | Honolulu | United States | 26 |
| 10 | Charlotte | United States | 23 |
Terminations
- Terminated
- 14
- Withdrawn
- 7
- Suspended
- 2
- Stopped for recruitment
- 1%3 of 306 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT04031469 Suspended | Suspended | Administrative | 2030-12-10 |
| NCT04224662 Withdrawn | Withdrawn | Company shifted focus | 2030-07-31 |
| NCT04844814 Suspended | Suspended | Peremption of treatments, difficulty of patients recrutment (28 patients in 3 years) and lack of funding to pursue the study. | 2026-08-31 |
| NCT06276556 Terminated | Terminated | For business consideration, a new long-term safety study will be conducted in the next new pivotal studies. | 2024-09-05 |
| NCT04697602 Terminated | Terminated | Slow recruitment | 2023-08-23 |
| NCT04072471 Withdrawn | Withdrawn | The study was withdrawn as lesinurad was withdrawn from the market in Europe by the market authorization holder. Hence the commitment to do this PASS was removed by the European Medicines Agency. | 2023-06-30 |
| NCT05256810 Terminated | Terminated | The Sponsor elected not to continue with the study | 2023-01-25 |
| NCT04987294 Terminated | Terminated | Company Financing | 2022-09-02 |
| NCT04839315 Terminated | Terminated | Difficulty with enrollment | 2022-02-09 |
| NCT04459936 Withdrawn | Withdrawn | The study has been terminated due to inclusion difficulties during the worldwide Covid-19 pandemic. | 2022-02-01 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: