Lidocaine Patch Versus Celecoxib in Pain From Osteoarthritis of the Knee

Endo Pharmaceuticals

Status and phase

Terminated

Phase 4

Conditions

Osteoarthritis of the Knee

Treatments

Drug: Celecoxib

Drug: Lidoderm

Study type

Interventional

Funder types

Industry

Identifiers

NCT00904605

EN3220-012

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)
Had functional capacity class rating of I, II, or III according to ACR classification
Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
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)
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.
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

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
Had elective surgery scheduled to occur during the 14-week study
Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that may confound study results
Had any other clinically significant joint disease or prior joint replacement surgery at the index joint
Had severe renal insufficiency (creatinine clearance of <30 mL/min)
Had moderate or greater hepatic impairment
Had experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Had a prior history of peptic ulcer disease and/or gastrointestinal bleeding
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.
Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the washout period.
Were receiving fluconazole or lithium (secondary to drug-drug-interaction risks)
Were taking a lidocaine-containing products that could not be discontinued during the study
Had previously failed treatment with Lidoderm analgesic patch for OA
Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry
Were unable to discontinue use of topic drugs applied to the knee
Had previously failed treatment with celecoxib or with two COX-2 specific inhibitors other than celecoxib
Were taking class I anti-arrhythmic drugs (e.g. mexiletine, tocainide)