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

• Sponsor: Endo Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00904462
• Collaborator: (none)
• Enrollment: 224
• Locations: 24
• Arms: 2
• Patients Per Site: 9.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: Lidoderm; Drug: Placebo patch	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Outcome Measures

Primary Outcome Measures

1. 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)]

2. 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)]

3. 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)]

4. 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)]

5. 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

1. 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)]

2. 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)]

3. Quality of Sleep (QOS) [Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)]

4. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Hueytown	Alabama	United States
3		Tallassee	Alabama	United States
4		Phoenix	Arizona	United States
5		Boulder	Colorado	United States
6		Deland	Florida	United States
7		Largo	Florida	United States
8		Palm Harbor	Florida	United States
9		St. Petersburg	Florida	United States
10		Chicago	Illinois	United States
11		Springfield	Illinois	United States
12		Wheaton	Maryland	United States
13		Peabody	Massachusetts	United States
14		Bingham Farms	Michigan	United States
15		Reno	Nevada	United States
16		Berlin	New Jersey	United States
17		Dayton	Ohio	United States
18		Oklahoma City	Oklahoma	United States
19		Duncansville	Pennsylvania	United States
20		Philadelphia	Pennsylvania	United States
21		Charleston	South Carolina	United States
22		Bartlett	Tennessee	United States
23		Cordova	Tennessee	United States
24		Memphis	Tennessee	United States

Sponsors and Collaborators

• Endo Pharmaceuticals

Investigators

• Study Director: Study Director, Endo Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00904462
• Other Study ID Numbers: EN3260-001
• First Posted: May 19, 2009
• Last Update Posted: Feb 10, 2010
• Last Verified: Feb 1, 2010

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Lidocaine

Study Results

No Results Posted as of Feb 10, 2010