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INTERNATIONAL STUDY, MULTICENTRIC, STRATIFIED, RANDOMIZED, DOUBLE-BLIND, WITH PLACEBO OVERLOAD, IN PARALLEL GROUPS, DURING 52 WEEKS OF GASTROINTESTINAL CLINICAL SECURITY, TO DEMONSTRATE THAT COX189 (400 MG / DAY OD) REDUCES THE RISK OF DISREGARDING COMPLICATED ULCERS COMPARING WITH NSAIDS (NAPROXENO 500 MG, BID AND IBUPROPHENE 800MG.ID) IN PATIENTS WITH OSTEOARTHRITIS, COX STUDY 1189 TARGET PART II

INTERNATIONAL STUDY, MULTICENTRIC, STRATIFIED, RANDOMIZED, DOUBLE-BLIND, WITH PLACEBO OVERLOAD, IN PARALLEL GROUPS, DURING 52 WEEKS OF GASTROINTESTINAL CLINICAL SECURITY, TO DEMONSTRATE THAT COX189 (400 MG / DAY OD) REDUCES THE RISK OF DISREGARDING COMPLICATED ULCERS COMPARING WITH NSAIDS (NAPROXENO 500 MG, BID AND IBUPROPHENE 800MG.ID) IN PATIENTS WITH OSTEOARTHRITIS, COX STUDY 1189 TARGET PART II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-022-02
Enrollment
75
Registered
2002-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

Naproxen Type of group
The patient is given naproxen of 500 mg for 52 weeks. Group name:Ibuprofen Type of group
The patient will be administered ibuprofen for 52 weeks

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: *Pacientes ambulatorios, mujeres u hombres que cooperen, de 50 años de edad o mas. *Pacientes con osteoartritis primaria con sintomas desde hace por lo menos 3 meses (el diagnostico puede efectuarse en la evaluacion). En cadera, rodilla o mano, de acuerdo a los criterios ACR

Exclusion criteria

Exclusion criteria: * Patients with rheumatoid arthritis who suffer from adult juvenile chronic arthritis. * Patient with secondary osteoarthritis with history and / or any evidence in the joint, fixed as a potential target, of the following diseases: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, disease Paget bone, fracture, oochronosis, acromegaly, hemochromatosis, Wilson´s disease, primary osteochondromatosis, hereditary disease (eg hypermobility), mutations of the collagen gene.

Design outcomes

Primary

MeasureTime frame
Outcome name:The investigator will perform an evaluation of the patient s conditions according to the standard medical treatment. Both for patients with OA and with RA, the same evaluation of the efficacy of the standard treatment will be carried out. Measure:Demonstrate that COX189 at a dose of 400 mg od decreases the incidence of complicated ulcers of the upper gastrointestinal tract predefined by at least 50%, compared to NSAIDs (naproxen 500 mg bid and ibuprofen 800 mg tid) in patients with rheumatoid arthritis (RA) ) and osteoarthritis (OA) that are not taking low doses of aspirin. Timepoints:week 8—

Secondary

MeasureTime frame
Outcome name:The age groups will be stratified as detailed below: 74 years. Approximately 76% of randomized patients will not take low doses of aspirin and 24% of randomized patients will take low doses of aspirin. Measure:To evaluate the cardiovascular and renal safety as well as the global profiles of safety and tolerability of COX 189 compared with NSAIDs. Timepoints:semana 8—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)