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Efficacy and safety of Acetaminophen in late stage gonarthrosis : A double-blind randomized placebo controlled trial study

Efficacy and safety of Acetaminophen in late stage gonarthrosis : A double-blind randomized placebo controlled trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221206005
Enrollment
216
Registered
2022-12-06
Start date
2023-01-10
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

Chronic mild to moderate pain in late-stage gonarthrosis late-stage knee osteoarthritis, paracetamol, placebo, numerical rating scale, modified WOMAC score, adverse events

Interventions

500 mg of Acetaminophen three times a day orally,The placebos look like Acetaminophen
Experimental Drug,Placebo Comparator Drug
Acetaminophen,Placebo

Sponsors

Navamindradhiraj university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Late stage primary knee osteoarthritis 50-75 years old with Chronic mild to moderate knee pain with Kellgren-Lawrence III-IV

Exclusion criteria

Exclusion criteria: Patients with non-ambulatory status; secondary knee osteoarthritis; severe pain or acute flare-up osteoarthritis; allergy to paracetamol or naproxen or omeprazole; preexisting routine consumption of other analgesic drugs; active hepatic disease with significant transaminitis; chronic renal disease with eGFR less than 30 mL/min/1.73m2; psychiatric disease needed treatment; history of gastritis or upper gastrointestinal bleeding; and other conditions using hepatotoxic drugs.

Design outcomes

Primary

MeasureTime frame
Pain control 2, 6, 12 weeks Numeric rating scale

Secondary

MeasureTime frame
Functional outcome 2, 6, 12 weeks Thai version of modified WOMAC score,Depression 2, 6,12 weeks Thai geriatric depression score-15,Liver function test 2, 6,12 weeks Total bilirubin, AST, ALT,Rescue drug 2, 6, 12 weeks Number of Naproxen use,Patient satisfaction 12 weeks Satisfied or Unsatisfied,Renal function test 2, 6, 12 weeks Creatinine and eGFR

Countries

Thailand

Contacts

Public ContactWaewwan Peungsomboonying

Faculty of Medicine Vajira Hospital, Navamindradhiraj university, Thailand

waewwan@nmu.ac.th022443276

Outcome results

None listed

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