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

Osteoarthritis, Knee Clinical Trial

Official title:

A Randomized, Double-Blind, Pilot Study Comparing the Efficacy and Safety of Lidocaine 5% Patch With Placebo in Patients With Pain From Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904462
• Other study ID #: EN3260-001
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2009
• Last updated: February 9, 2010
• Start date: August 2004

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Quality of Sleep (QOS)		Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)	No
Secondary	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)	Yes