Acute Crystal-Induced Arthritis Gout Acute Calcium Pyrophosphate Crystal Arthritis Acute crystal-induced arthritis gout flare gouty arthritis gout gout attack calcium pyrophosphate deposition disease CPPD colchicine tramadol pain randomized controlled trial double-blind
Conditions
Interventions
Participants randomized to this arm will receive tramadol capsules prepared according to the approved protocol. Matching encapsulation will be used to maintain blinding.
Tramadol 1*3 po pc for 5 days,
Experimental Drug,Active Comparator Drug
Tramadol,Colchicine
Sponsors
Thai Rheumatism Association
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older. 2. Able to read and write Thai. 3. Able to communicate by telephone. 4. Acute arthritis defined as joint pain with physical examination findings of arthritis, including swelling, redness, warmth, and tenderness, with symptom onset within 48 hours before randomization. 5. Diagnosis of acute crystal-induced arthritis, including gout or acute calcium pyrophosphate crystal arthritis, based on established ACR/EULAR classification criteria, crystal identification, or scoring criteria as specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Contraindication, allergy, or clinically significant intolerance to colchicine, tramadol, or opioids, as specified in the protocol. 2. Use of nonsteroidal anti-inflammatory drugs, colchicine, opioids, or oral or injectable corticosteroids within 1 week before enrollment. 3. Inability to take oral study medication. 4. Inability to assess or report pain score. 5. Severe renal impairment, including eGFR less than 30 mL per min per 1.73 m2, dialysis, or acute kidney injury according to protocol criteria. 6. Severe hepatic impairment or decompensated liver disease according to protocol criteria. 7. Use of medications with clinically significant interactions with colchicine or tramadol, including strong CYP3A4 inhibitors, P glycoprotein inhibitors, or medications that increase risk of serotonin syndrome or seizures, as specified in the protocol. 8. Pregnancy or breastfeeding. 9. Any condition that, in the investigator s judgment, may pose a safety risk or make the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Baseline to 24 Hours Change in Target Joint Pain Numeric Rating Scale Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Day 1 to Day 7 Daily Target Joint Pain Numeric Rating Scale Score,Pain Day 1 to Day 7 Time to Complete Pain Resolution,Swelling Day 1 to Day 7 Target Joint Swelling Score,Tenderness Day 1 to Day 7 Target Joint Tenderness Score,Patient Global Assessment Day 1 to Day 7 Patient Global Assessment of Disease Activity,Functional disability Day 1 to Day 7 Thai Health Assessment Questionnaire Score,Health-related quality of life Day 1 to Day 7 EQ-5D-5L Health State and EQ VAS Score,Recurrent flare Within 14 days Proportion of Participants With Recurrent Flare,Safety Through study follow-up Number of Serious Adverse Events,Safety Day 1 to Day 7, and as clinically assessed Solicited Adverse Events by Type and Severity | — |
Countries
Thailand
Contacts
Public ContactWattanapop Plagatong
Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed