Lidocaine Patch Versus Celecoxib in Pain From Osteoarthritis of the Knee

A Randomized, Open-Label Study Comparing the Efficacy and Safety of Lidocaine Patch 5% With Celecoxib 200 mg in Patients With Pain From Osteoarthritis of the Knee

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: Lidoderm; Drug: Celecoxib

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Hueytown, Alabama, United States
  • Arizona
    • Mesa, Arizona, United States
    • Oro Valley, Arizona, United States
    • Phoenix, Arizona, United States
  • California
    • Carlsbad, California, United States
  • Florida
    • Daytona, Florida, United States
    • Gainesville, Florida, United States
    • Inverness, Florida, United States
    • Melbourne, Florida, United States
    • Miami, Florida, United States
    • Port Orange, Florida, United States
    • Sarasota, Florida, United States
  • Georgia
    • Decatur, Georgia, United States
    • Marietta, Georgia, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • Michigan
    • Bingham Farms, Michigan, United States
  • North Carolina
    • Clemmons, North Carolina, United States
    • Winston Salem, North Carolina, United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
    • Johnstown, Pennsylvania, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1- Lidoderm®; Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied topically to each affected knee every 24 hours (q24h)	Drug: Lidoderm; 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
Active Comparator: 2-Celecoxib 200mg; Celecoxib (Celebrex®, G.D. Searle & Co., Chicago, IL), one 200 mg oral capsule QD	Drug: Celecoxib; 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)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimate): May 19, 2009

Study Record Updates

• Last Update Posted (Estimate): February 15, 2010
• Last Update Submitted That Met QC Criteria: February 12, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: EN3220-012