None listed
Conditions
Interventions
Group 1 Type of group
Diclofenac 50 mg + Paracetamol 500 mg every 8 hours for 14 days
Group name:Group 3 Type of group
Paracetamol 500 mg PO every 8 hours for 14 days
Sponsors
BRISTOL MYERS SQUIBB PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients of both sexes, over 18 years old and under 65 years old. • Osteoarthritis of the knee, defined by clinical symptoms (crunching and / or volume increase dependent on bone parts) and / or characteristic radiological changes. • Pain with / without temperature increase and / or spill. • Primary osteoarthrosis. • Not having ingested steroid or nonsteroidal anti-infammatory drugs (AlNEs) in the 2 weeks prior to the study. • Sign the informed consent
Exclusion criteria
Exclusion criteria: • Under 18 and over 65 years old. • Pregnancy or breastfeeding. • History of gastrointestinal bleeding or Active Aetiopic Disease. • Hepatic and / or renal insufficiency. • Bronchospasm. • Blood dyscrasias or treatment with anticoagulants. • Allergy to diclofenac and / or acetaminophen. • Intra-articular infiltration in the last 4 weeks. • Have swallowed anti-inflammatories in the previous 2 weeks. • Anemia • Uncontrolled arterial hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:In the control visits, the patient will fill out a form that includes the following information: to. Subjective assessment of the patient (night pain): 0 = worse 1 = equal 2 = better 3 = disappearance b. Morning stiffness: minutes c. Analogous visual pain scale: O -10, reconstructing the pain intensity of each day of treatment based on memory. d. Physical examination: objective assessment by the doctor of pain and inflammation: pain to passive and active movement, increase in local temperature, presence of effusion, diameter of the knee, angle of knee flexion to passive movement (measured in degrees with a goniometer), time (seconds) in travel 10 meters. Cure: Disappearance of pain Improvement: Decreased symptoms, functional improvement Failure: Pain that requires local infiltration, parenteral therapy or change of treatment. Measure:Pain Evaluation Timepoints:During treatment administration and follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Gastrointestinal toxicity: presence of epigastric burning, nausea, vomiting, diarrhea, abdominal pain, melena, hematemesis. • Dermal toxicity: rash, pruritus, hypersensitivity reactions. • Other clinical adverse effects • Laboratory: at visit 0 and at the end of the study (visit 4), blood will be drawn for analysis of: hematocrit, blood count, creatinine, transaminases, urine test, thevenon in faeces. Measure:Tolerance and Safety Timepoints:During treatment administration and follow up. | — |
Outcome results
None listed