Phase 2
N=169
Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT00589979 ↗Enrolled (actual)
169
Serious AEs
0.9%
Results posted
Sep 2010
Primary outcome: Primary: Time-to-Exit From Current Study Treatment — 31; 20; NA; NA Days — p=0.1006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lidoderm (Lidocaine 5% Patch) (Drug); Placebo Patch (Drug)
- Age
- Adult, Older Adult · 37+ yrs
- Sex
- All
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-to-Exit From Current Study Treatment |
31; 20; NA; NA; NA; NA | 0.1006 |
| SECONDARY Time-to-Exit Due to Lack of Efficacy |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Exit Status From Current Study Treatment - Yes |
10; 12; 5; 4; 6; 2 | 0.1272 |
| SECONDARY Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS) |
3.03; 3.57 | 0.0224 sig |
| SECONDARY Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores |
4.45; 4.06 | 0.2747 |
| SECONDARY Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores |
3.31; 3.53; 2.50; 3.00; 1.12; 1.59 | 0.4498 |
| SECONDARY Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain |
3; 5; 3; 2; 4; 4 | 0.3185 |
| SECONDARY Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain |
3; 4; 2; 3; 5; 4 | 0.4748 |
| SECONDARY Patient Global Assessment of Treatment Satisfaction |
12; 9; 8; 10; 12; 12 | 0.2605 |
| SECONDARY Investigator Global Assessment of Treatment Satisfaction |
7; 6; 5; 8; 8; 11 | 0.3193 |
Summary
Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.
Eligibility Criteria
Key Inclusion criteria
- Male or female patients ≥37 years with moderate-to-severe OA related pain in one knee
- Body mass index (BMI) ≤40 kg/m2
- Symptomatic OA of the index knee diagnosed with a functional capacity of II or III according to ACR criteria classification Note: Patients with symptomatic contralateral knee OA with persistent pain ≤2 cm on a 0-10 cm PI-NRS for ≥2 months will be allowed to participate.
- Unchanged dose of analgesic medication for OA for at least 4 weeks prior to screening and for the duration of the study
- Able and willing to complete all paper and e-diary assessments required by protocol
Key Exclusion criteria
- Pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint
- Compromised integrity of the intact, superficial skin layer
- A grade 1 or 4 Kellgren and Lawrence score on radiographic examination
- Recent injury to either knee causing pain and interference with daily activities (eg. walking)
- Recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and QoL
- Known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product
Data sourced from ClinicalTrials.gov (NCT00589979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.