Primary osteoarthritis of the hip MedDRA version: 8.0 Level: LLT Classification code 10020108
Conditions
Interventions
Trade Name: PREXIGE
Product Name: Prexige
Product Code: COX189
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lumiracoxib
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of lumiracoxib in primary hip osteoarthritis by testing the hypotheses that lumiracoxib 100 mg o.d. is superior to placebo with respect to the pain sub-scale of the WOMAC 3.1LK questionnaire, the difficulty performing daily activities (DPDA) sub-scale of the WOMAC 3.1LK questionnaire, and patient's global assessment of disease activity on a 100 mm VAS after 13 weeks of treatment; Secondary Objective: 1. To assess the safety and tolerability of lumiracoxib 100 mg o.d. in comparison to placebo and celecoxib 200 mg o.d. 2. To assess the efficacy of lumiracoxib 100 mg o.d. as compared to placebo, with celecoxib 200 mg o.d. as a positive control, using the following secondary efficacy variables: overall OA pain intensity (VAS), physician's global assessment of disease activity (VAS), response to treatment according to OARSI criteria, actual OA pain intensity at 12 hours post-dose and number of acetaminophen/paracetamol rescue tablets taken during the study. ; Primary end point(s): 1. WOMAC pain sub-scale score at 13 weeks 2. Patient's global assessment of disease activity at 13 weeks (0-100 mm VAS) 3. WOMAC DPDA (difficulty in performing daily activities; a measure of function) sub-scale score at 13 weeks | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed