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Efficacy and safety of NSAIDs spray for pain relieving in patients with acute gouty arthritis : a randomized control trial

Efficacy and safety of NSAIDs spray for pain relieving in patients with acute gouty arthritis : a randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230208012
Enrollment
112
Registered
2023-02-08
Start date
2023-01-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

change of pain-VAS score in acute gout flare between 2 arms Acute gout flare, topical NSAIDs, NSAIDs spray, gout

Interventions

Colchicine 1.2 mg stat then 0.6 po q 12 hr plus 1%diclofenac sodium spray total 7 day,Colchicine 1.2 mg stat then 0.6 po q 12 hr plus NSS spray total 7 day
Active Comparator Drug,Placebo Comparator Drug
1%diclofenac sodium spray ,NSS spray

Sponsors

Navamindradhiraj University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Patient age 18 year or more 2.Patient classified having gout with ACR/EULAR classification criteria 2015 present with Acute arthritis

Exclusion criteria

Exclusion criteria: Participant can not communicate or follow command : confusion, coma Contraindications for colchicine, topical NSAIDs Concomitant with other diagnosis : RA, PSA, septic arthritis, CPPD ICU patient : post cardiac arrest, septic shock, acute respiratory failure on ventilator NSAIDs, steroid, colchicine before start treatment Initial eGFR below 30 ml/min/1.73m2 Acute gout flare duration > 5 day

Design outcomes

Primary

MeasureTime frame
Pain 2 day after treatment Visual analogue scale

Secondary

MeasureTime frame
Safety 7 day Patient report, Creatinine, AST, ALT, ALT,Safety 2 day Patient report

Countries

Thailand

Contacts

Public ContactAksika Saling

Faculty of Medicine Vajira Hospital Navamindradhiraj University

Aksika.sal@nmu.ac.th022443461

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026