Lidocaine Patch Versus Celecoxib in Pain From Osteoarthritis of the Knee

This study has been terminated.
(Safety concerns with the COX-2 specific inhibitor class of drug.)
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904605
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Lidoderm
Drug: Celecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Mean change from baseline to Week 12 in Western Ontario and McMaster Universities OA Index (WOMAC) pain subscale [ Time Frame: Visits - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Study Start Date: June 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904605

Locations
United States, Alabama
Hueytown, Alabama, United States
United States, Arizona
Mesa, Arizona, United States
Oro Valley, Arizona, United States
Phoenix, Arizona, United States
United States, California
Carlsbad, California, United States
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
United States, Georgia
Decatur, Georgia, United States
Marietta, Georgia, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Michigan
Bingham Farms, Michigan, United States
United States, North Carolina
Clemmons, North Carolina, United States
Winston Salem, North Carolina, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Johnstown, Pennsylvania, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Sr. Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00904605     History of Changes
Other Study ID Numbers: EN3220-012
Study First Received: May 15, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Celecoxib
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 31, 2014