Lidocaine Patch Versus Celecoxib in Pain From Osteoarthritis of the Knee

NCT ID: NCT00904605

Last Updated: 2010-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2004-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1- Lidoderm®

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

Group Type: EXPERIMENTAL

Lidoderm

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: 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)

Interventions

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

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Endo Pharmaceuticals Inc.

Principal Investigators

Sr. Director

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Hueytown, Alabama, United States

Mesa, Arizona, United States

Oro Valley, Arizona, United States

Phoenix, Arizona, United States

Carlsbad, California, United States

Daytona Beach, 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

Decatur, Georgia, United States

Marietta, Georgia, United States

New Orleans, Louisiana, United States

Bingham Farms, Michigan, United States

Clemmons, North Carolina, United States

Winston-Salem, North Carolina, United States

Duncansville, Pennsylvania, United States

Johnstown, Pennsylvania, United States

Countries

United States

Other Identifiers

EN3220-012

Identifier Type: -

Identifier Source: org_study_id