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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904462
First received: May 15, 2009
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: Lidoderm
Drug: Placebo patch
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities (WOMAC) OA Index [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: No ]
  • Pain intensity and pain relief (BPI Questions 3, 4, 5, 6, and 8) [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: No ]
  • Pain Quality Assessment Scale (PQAS) [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: No ]
  • Patient-rated and Investigator-rated Global Impression of Change in OA pain (categorical scale) [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: No ]
  • Patient-rated and Investigator-rated Global Assessment of Treatment Satisfaction (categorical scale) [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QoL: Pain interference on activities of daily living using Question 9 of the BPI [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: No ]
  • QoL: Beck Depression Inventory (BDI) [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: No ]
  • Quality of Sleep (QOS) [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: No ]
  • Safety assessments included AEs, dermal assessments, clinical laboratory tests (including urinalysis), vital sign measurements, physical examination results, and plasma lidocaine concentrations [ Time Frame: Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) ] [ Designated as safety issue: Yes ]

Enrollment: 224
Study Start Date: August 2004
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine 5% patch
Lidocaine 5% patch (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied on each affected knee once every 24 hours
Drug: Lidoderm
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Other Name: Lidocaine 5% patch
Placebo Comparator: Placebo patch
Matching placebo patch, 1⅓ patches applied on each affected knee once every 24 hours
Drug: Placebo patch
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904462

  Show 24 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Study Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00904462     History of Changes
Other Study ID Numbers: EN3260-001
Study First Received: May 15, 2009
Last Updated: February 9, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014