Lidocaine Patch Versus Celecoxib in Pain From Osteoarthritis of the Knee

NCT00904605 | Terminated Phase 4

• 1 other identifier: EN3220-012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 20

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.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1- Lidoderm®

EXPERIMENTAL

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied topically to each affected knee every 24 hours (q24h)

Drug: Lidoderm

2-Celecoxib 200mg

ACTIVE COMPARATOR

Celecoxib (Celebrex®, G.D. Searle \& Co., Chicago, IL), one 200 mg oral capsule QD

Drug: Celecoxib

Interventions

Lidoderm DRUG

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

1- Lidoderm®

Celecoxib DRUG

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)

2-Celecoxib 200mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (20)

Unknown Facility

Hueytown, Alabama, United States

Location

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Mesa, Arizona, United States

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Oro Valley, Arizona, United States

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Phoenix, Arizona, United States

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Carlsbad, California, United States

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Daytona Beach, Florida, United States

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Gainesville, Florida, United States

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Inverness, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Port Orange, Florida, United States

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Sarasota, Florida, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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New Orleans, Louisiana, United States

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Bingham Farms, Michigan, United States

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Clemmons, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Duncansville, Pennsylvania, United States

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Johnstown, Pennsylvania, United States

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Lidoderm; Celecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sr. Director

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 19, 2009
• Study Start: June 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: February 15, 2010

Record last verified: 2010-02

Locations

US (20)