Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Gout would be drug repurposing rather than first-in-human development. This does not mean it is approved for Gout. ClinicalTrials.gov lists 8 registered trials linking Indomethacin to Gout: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00170781). The largest enrolment is 402 participants (NCT00549549). Registration activity spans 1998 to 2024. The literature layer holds 9 publications for this pair: 2 Cochrane reviews, 2 meta-analyses and 5 clinical trial publications. Publication years run from 2009 to 2020. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Gout ranks 186 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Acute flares self-resolve in 7-14 days without treatment; but urate crystal deposition continues; only 10-15% achieve serum urate <360 µmol/L spontaneously without ULT; progressive tophus formation and joint damage in untreated patients.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 76.5 (trials 28.5, literature 28.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 9 (5 clinical trial publications, 2 Cochrane reviews, 2 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | AAK1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00142558 | A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED) 2005 | completed | Phase 4 | 180 |
| NCT01310673 | Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout 1998 | completed | Phase 4 | 57 |
| NCT00170781 | Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout 2005 | completed | Phase 4 | 234 |
| NCT00549549 | Celebrex In Acute Gouty Arthritis Study 2008 | completed | Phase 3 | 402 |
| NCT00855920 | Study Utilizing Rilonacept in Gout Exacerbations 2009 | completed | Phase 3 | 225 |
| NCT00997581 | Apremilast Therapy for Acute Gouty Arthritis 2010 | withdrawn | Phase 2 | — |
| NCT01884272 | NSAID Drug Interaction Study 2013 | completed | Phase 1 | 24 |
| NCT06273813 | Treatment of Topical Ketorolac Gel in Acute Gouty Flare 2024 | status unknown | Phase 1 | 30 |
Published literature
- Meta-analysis Comparative efficacy of traditional non-selective NSAIDs and selective cyclo-oxygenase-2 inhibitors in patients with acute gout: a systematic review and meta-analysisLi M, Yu C, Zeng X · BMJ open · 2020 · PMID 32912981
- Meta-analysis Oral prednisolone versus non-steroidal anti-inflammatory drugs in the treatment of acute gout: a meta-analysis of randomized controlled trialsYu J, Lu H, Zhou J et al. · Inflammopharmacology · 2018 · PMID 29357007
- Cochrane review Benefit-risk of corticosteroids in acute gout patients: An updated meta-analysis and economic evaluationLiu X, Sun D, Ma X et al. · Steroids · 2017 · PMID 28899726
- Clinical trial publication Comparison of Prednisolone, Etoricoxib, and Indomethacin in Treatment of Acute Gouty Arthritis: An Open-Label, Randomized, Controlled TrialXu L, Liu S, Guan M et al. · Medical science monitor : international medical journal of experimental and clinical research · 2016 · PMID 26965791
- Clinical trial publication Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized TrialRainer TH, Cheng CH, Janssens HJ et al. · Annals of internal medicine · 2016 · PMID 26903390
- Cochrane review Interleukin-1 inhibitors for acute goutSivera F, Wechalekar MD, Andrés M et al. · The Cochrane database of systematic reviews · 2014 · PMID 25177840
- Clinical trial publication Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparatorTerkeltaub RA, Schumacher HR, Carter JD et al. · Arthritis research & therapy · 2013 · PMID 23375025
- Clinical trial publication Initiation of allopurinol at first medical contact for acute attacks of gout: a randomized clinical trialTaylor TH, Mecchella JN, Larson RJ et al. · The American journal of medicine · 2012 · PMID 23098865
- Clinical trial publication Serum urate during acute goutSchlesinger N, Norquist JM, Watson DJ · The Journal of rheumatology · 2009 · PMID 19369457
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AAK1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Gout?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Gout would be drug repurposing rather than first-in-human development. This does not mean it is approved for Gout. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Gout?
ClinicalTrials.gov lists 8 registered trials linking Indomethacin to Gout: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00170781). The largest enrolment is 402 participants (NCT00549549). Registration activity spans 1998 to 2024.
What does the evidence show for Indomethacin in Gout?
Indomethacin has both completed registered trials and synthesis-level publications linked to Gout. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AAK1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.