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

Phase 2

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Placebo patch; Drug: Lidoderm

• Registration Number: NCT00904462
• Lead Sponsor: Endo Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-09
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-09
• Last Update Posted: 2010-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Key

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities (WOMAC) OA Index	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Pain intensity and pain relief (BPI Questions 3, 4, 5, 6, and 8)	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Pain Quality Assessment Scale (PQAS)	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Patient-rated and Investigator-rated Global Impression of Change in OA pain (categorical scale)	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Patient-rated and Investigator-rated Global Assessment of Treatment Satisfaction (categorical scale)	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)

Secondary Outcome Measures

Name	Time	Method
QoL: Pain interference on activities of daily living using Question 9 of the BPI	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
QoL: Beck Depression Inventory (BDI)	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Quality of Sleep (QOS)	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Safety assessments included AEs, dermal assessments, clinical laboratory tests (including urinalysis), vital sign measurements, physical examination results, and plasma lidocaine concentrations	Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)