Double blind, comparative study to evaluate the efficacy and tolerance of Dolocordralan Forte (Diclofenac 25 mg + Acetaminophen 500 mg) vs. Acetaminophen in the Treatment of Acute Exacerbation of Knee Osteoarthritis

Not Applicable

• Conditions: -M179 Gonarthrosis, unspecified; Gonarthrosis, unspecified; M179

• Registration Number: PER-036-99
• Lead Sponsor: BRISTOL MYERS SQUIBB PERÚ S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-03-03
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:In the control visits, the patient will fill out a form that includes the following information:<br>to. Subjective assessment of the patient (night pain):<br>   0 = worse<br>   1 = equal<br>   2 = better<br>   3 = disappearance<br>b. Morning stiffness: minutes<br>c. Analogous visual pain scale: O -10, reconstructing the pain intensity of each day of treatment based on memory.<br>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<br>(measured in degrees with a goniometer), time (seconds) in<br>travel 10 meters.<br><br>Cure: Disappearance of pain<br>Improvement: Decreased symptoms, functional improvement<br>Failure: Pain that requires local infiltration, parenteral therapy or change of treatment.<br>Measure:Pain Evaluation<br>Timepoints:During treatment administration and follow up.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:• Gastrointestinal toxicity: presence of epigastric burning, nausea, vomiting, diarrhea, abdominal pain, melena, hematemesis.<br>• Dermal toxicity: rash, pruritus, hypersensitivity reactions.<br>• Other clinical adverse effects<br>• 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.<br>Measure:Tolerance and Safety<br>Timepoints:During treatment administration and follow up.<br>