A 13-week, multicenter, randomized, double-blind, double-dummy,placebo-controlled, parallel group trial oflumiracoxib (COX189) 100 mg o.d. in patients with primaryhip osteoarthritis using celecoxib (200 mg o.d.) as apositive control

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1200

Inclusion Criteria

At screening (Visit 1):
1. Male or female outpatients 40 years of age or older
2. Who have the highest pain intensity occurring in the target hip joint, relative to other OA joints (including the contralateral hip).
3. With a diagnosis of primary hip osteoarthritis which meets ACR criteria and have symptoms present for at least 3 months prior to screening. Diagnosis can be made at screening if symptoms have been present for 3 months by history.
4. Who have taken NSAIDs or simple analgesic therapy at least 50% of the time in the previous month (i.e. for 15 or more days (either successive or not) in the past 30 days) and who in the opinion of the investigator will require NSAID therapy for at least 13 weeks.
5. Who have sedentary pain (pain while sitting or lying down) for at least 2 days of the week and non-sedentary pain for at least 50% of the days in the previous month (i.e. for 15 or more days (either successive or not) in the past 30 days).
6. And who present at Baseline (Visit 2) with an:
OA pain intensity of at least 40 mm (0-100 mm VAS) in the target hip during the last 24 hours, and an increase in OA pain intensity since the screening visit of >= 20% and >= 10mm. Those patients who reach 100 mm before achieving a 20% increase will still be eligible as long as the increase is at least 10 mm.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Who have OA pain intensity of the knee(s) >= 30 mm (0-100 mm VAS) at screening.
2. With symptomatic osteoarthritis of the contralateral hip or spine that may, in the investigator's opinion, interfere with assessment of the target hip joint.
3. With secondary osteoarthritis with history and/or any evidence in the potential target joint of the following diseases: septic arthritis, gout, recurrent episodes of pseudogout, Paget's disease of bone, articular fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility), or collagen gene mutations
4. With primary fibromyalgia (secondary fibromyalgia is allowed if, in the opinion of the investigator it will not interfere with the patient's OA pain assessment)
5. Who had open knee/hip surgery within the last year, or observational arthroscopy, arthroscopic surgery or lavage within the last 180 days (in the knee or hip).
6. Who expect, or in the opinion of the investigator are expected, to have replacement of the target joint within 4 months of enrollment
7. With rheumatoid arthritis, systemic lupus erythematosus, or other inflammatory joint disease
8. With adult juvenile chronic arthritis (juvenile chronic arthritis with continued activity in adulthood)
9. With sarcoidosis
10. With symptomatic (source of hip pain) trochanteric bursitis of the target joint
11. With complete, even if focal, loss of articular cartilage on weight-bearing X-ray of the target joint

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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