Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the Knee

NCT ID: NCT00904462

Last Updated: 2010-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31

Brief Summary

Patients with unilateral or bilateral osteoarthritis (OA) of the knee participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo in the treatment of pain from OA of the knee.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine 5% patch

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

Group Type: EXPERIMENTAL

Lidoderm

Intervention Type: DRUG

Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

Placebo patch

Matching placebo patch, 1⅓ patches applied on each affected knee once every 24 hours

Group Type: PLACEBO_COMPARATOR

Placebo patch

Intervention Type: DRUG

Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

Interventions

Lidoderm

Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

Intervention Type: DRUG

Placebo patch

Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

Intervention Type: DRUG

Other Intervention Names

Lidocaine 5% patch

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 (presence of osteophytes on x-ray and written evaluation) of OA

2. Had functional capacity class rating of I, II, or III according to ACR classification

3. Had 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 double-blind treatment if they had an average pain intensity rating for the index joint of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to 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 double-blind treatment if they had, at the baseline visit, 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 have interfered with the assessment of pain and other symptoms of OA

2. Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that could have confounded study results

3. Had any other clinically significant joint disease or prior joint replacement surgery at the index joint

4. Had severe renal insufficiency (creatinine clearance of <30 mL/min)

5. Had moderate or greater hepatic impairment

6. 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.

7. Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period.

8. Were using lidocaine-containing product that could not be discontinued during the study

9. Had previously failed treatment with Lidoderm analgesic patch for OA

10. Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry

11. Were unable to discontinue use of topical drugs applied to the knee

12. 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

Study Director

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Birmingham, Alabama, United States

Hueytown, Alabama, United States

Tallassee, Alabama, United States

Phoenix, Arizona, United States

Boulder, Colorado, United States

DeLand, Florida, United States

Largo, Florida, United States

Palm Harbor, Florida, United States

St. Petersburg, Florida, United States

Chicago, Illinois, United States

Springfield, Illinois, United States

Wheaton, Maryland, United States

Peabody, Massachusetts, United States

Bingham Farms, Michigan, United States

Reno, Nevada, United States

Berlin, New Jersey, United States

Dayton, Ohio, United States

Oklahoma City, Oklahoma, United States

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Bartlett, Tennessee, United States

Cordova, Tennessee, United States

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

EN3260-001

Identifier Type: -

Identifier Source: org_study_id