Osteoarthritis of the Knee
Conditions
Brief summary
Patients with unilateral or bilateral osteoarthritis of the knee participated in a Phase IV clinical trial to assess the efficacy of Lidoderm compared with celecoxib 200mg in treating pain from osteoarthritis of the knee.
Interventions
DRUGLidoderm
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine patch 5% or celecoxib 200 mg daily. Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied topically to each affected knee every 24 hours (q24h
DRUGCelecoxib
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine patch 5% or celecoxib 200 mg daily. Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied topically to each affected knee every 24 hours (q24h)
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Had unilateral or bilateral OA of the knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence of OA (presence of osteophytes on x-ray and written evaluation) 2. Had functional capacity class rating of I, II, or III according to ACR classification 3. Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction 4. Had discontinued use of all analgesic medications (including over-the-counter \[OTC\] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for non-study pain) 5. At baseline visit, patients were randomized to active treatment if they had an average daily pain intensity score for the index joint of 5 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately preceding the baseline visit; 0 is defined as no pain and 10 is defined as pain as bad as ever imagined as measured by Question 5 of the BPI and recorded in a diary. 6. At baseline visit, patients were randomized to active treatment if they had an OA severity score for the index joint of 7 or greater on a composite scale of 0 to 24 as measured by the Index of Severity for Osteoarthrosis of the Knee
Exclusion criteria
1. Had been diagnosed with inflammatory arthritis, gout, pseudo-gout or Paget's disease that in the investigator's opinion would interfere with the assessment of pain and other symptoms of OA 2. Had elective surgery scheduled to occur during the 14-week study 3. Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that may confound study results 4. Had any other clinically significant joint disease or prior joint replacement surgery at the index joint 5. Had severe renal insufficiency (creatinine clearance of \<30 mL/min) 6. Had moderate or greater hepatic impairment 7. Had experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs 8. Had a prior history of peptic ulcer disease and/or gastrointestinal bleeding 9. Were taking analgesic medications, glucosamine, or chondroitin that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications. 10. Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the washout period. 11. Were receiving fluconazole or lithium (secondary to drug-drug-interaction risks) 12. Were taking a lidocaine-containing products that could not be discontinued during the study 13. Had previously failed treatment with Lidoderm analgesic patch for OA 14. Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry 15. Were unable to discontinue use of topic drugs applied to the knee 16. Had previously failed treatment with celecoxib or with two COX-2 specific inhibitors other than celecoxib 17. Were taking class I anti-arrhythmic drugs (e.g. mexiletine, tocainide)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to Week 12 in Western Ontario and McMaster Universities OA Index (WOMAC) pain subscale | Visits - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessments included AEs, Dermal assessment (lidocaine group only), skin sensory testing (lidocaine group only), clinical laboratory test results (including urinalysis), vital sign measurements, physical examination results, body weight, plasma | — |
Countries
United States
Outcome results
None listed