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STUDY OF 26 WEEKS, MULTICENTER, INTERNATIONAL, RANDOMIZED, DOUBLE BLIND, WITH PLACEBO OVERLOAD IN PARALLEL GROUPS, CONTROLLED WITH PLACEBO AND ACTIVE DRUG OF 2 DOSE OF COX189 (200 Y400MG DAILY ONCE A DAY) IN PATIENTS WITH PRIMARY KNEE OSTEOARTHRITIS USING NAPROXENO (500 MG TWICE A DAY) AS AN ACTIVE COMPARATOR.

STUDY OF 26 WEEKS, MULTICENTER, INTERNATIONAL, RANDOMIZED, DOUBLE BLIND, WITH PLACEBO OVERLOAD IN PARALLEL GROUPS, CONTROLLED WITH PLACEBO AND ACTIVE DRUG OF 2 DOSE OF COX189 (200 Y400MG DAILY ONCE A DAY) IN PATIENTS WITH PRIMARY KNEE OSTEOARTHRITIS USING NAPROXENO (500 MG TWICE A DAY) AS AN ACTIVE COMPARATOR.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-044-02
Enrollment
Unknown
Registered
2002-07-05
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

400 mg of COX189 Type of group
COX189 400mg (two tablets of COX189 200mg o.d. + naproxen placebo) Group name:Naproxen 500mg Type of group
Naproxen (Naproxen 500mg b.l.d. + 2X COX189 placebo)

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients of both sexes> 18 years of age. • Primary osteoarthritis of the knee, with diagnosis and documented symptoms for at least 3 months (diagnosis can be made during the selection). • Baseline pain intensity of at least 40 mm (VAS 0-100 mm) in the white joint of the study during the last 24 hours. • Currently in treatment with NSAIDs or other simple analgesic, or who are not in treatment but are expected to need treatment with NSAIDs for at least 6 months.

Exclusion criteria

Exclusion criteria: • Secondary osteoarthritis with a history. • History of malignant disease in any organic system (treated or untreated) during the last five years. • Open knee surgery during the previous year. Observational arthroscopy, arthroscopic surgery or knee washing during the last 6 months. • Evidence of active peptic ulcer during the previous 12 months.

Design outcomes

Primary

MeasureTime frame
Outcome name:Visual Analog Scale (VAS) of 0-100 mm Measure:COX189 (200mg or 400mg o.d.) is effective in knee osteoarthritis (OA) compared to placebo with respect to pain intensity. Timepoints:26 weeks—

Secondary

MeasureTime frame
Outcome name:SF-36 questionnaire Measure:Functional health status of the patient and patient satisfaction. Timepoints:13 y 26 weeks—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)