Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Patients who had axial lower back pain (LBP) with or without radiation present for at least 3 months and had daily moderate to severe LBP as the primary source of pain participated in a Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib 200 mg in treating chronic axial LBP with and without radiation.

Official Title
-----------------
A Randomized, Open-Label Study Comparing the Efficacy and Safety of Lidocaine Patch 5% With Celecoxib 200 mg in Patients With Chronic Axial Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Drug: Lidoderm®
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had axial LBP with or without radiation present for at least 3 months as defined below: Chronic axial LBP without radiation: pain isolated to the axial low back without radiation into the buttock or below Chronic axial LBP with radiation: pain that radiated to the buttock or below. This patient group could include patients with radicular/neuropathic and non-radicular components with leg pain component <50% Had daily moderate to severe LBP as the primary source of pain Had a normal neurological examination, including: Motor strength Sensory exam in lower extremities Deep tendon reflexes Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics), glucosamine, and chondroitin prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain At the baseline visit, patients were randomized to active treatment if they had an average daily pain intensity score of 5 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 was defined as no pain and 10 was defined as pain as bad as ever imagined as measured by Question 5 of the Brief Pain Inventory (BPI) and recorded in a diary Exclusion Criteria: Had spinal stenosis with >50% leg pain component Had any other chronic pain condition that, in the opinion of the investigator, would interfere with patient assessment of LBP relief Had a history of one or more back surgeries within 1 year of study entry Had a moderate or greater hepatic impairment Had a severe renal insufficiency (creatinine clearance of <30 mL/min) Had experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) Had a prior history of peptic ulcer disease and/or gastrointestinal (GI) bleeding Were taking analgesic medications 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. Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the washout period Were receiving fluconazole or lithium (secondary to drug-drug-interaction risks with celecoxib) Had received an epidural steroid/local anesthetic injection within 4 weeks prior to study entry Had received trigger point injections within 2 weeks prior to study entry Had received Botulinum Toxin (Botox) injections for LBP within 6 months prior to study entry Were using a lidocaine-containing product that cannot be discontinued during the study Were using any topical medication applied to the low back region Had previously failed treatment with Lidoderm analgesic patch for LBP Had previously failed treatment with celecoxib or with any two COX-2 specific inhibitors other than celecoxib Were taking class I anti-arrhythmic (e.g. mexiletine, tocainide) Had a history of alcohol or substance abuse within the last 3 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidoderm<br>Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 2 patches applied once daily (q24h) directly to the most painful area of the low back | Drug: Lidoderm®<br>* Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.<br>* Other names: Lidocaine patch 5%;|
| Active Comparator: Celecoxib<br>Celecoxib (Celebrex®, G.D. Searle & Co., Chicago, IL), one 200 mg oral capsule QD | Drug: Celecoxib<br>* Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to Week 12 in BPI average pain intensity score (Question 5). |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in daily pain intensity score as measured by Questions 3, 4, 5, and 6 of the BPI |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in BPI pain relief score (Question 8). |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in PQAS composite scores |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in Oswestry Disability Index composite scores |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Investigator's Global Impression of Change in LBP at Week 12 (or premature discontinuation) |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Patient's Global Impression of Change in LBP at Week 12 (or premature discontinuation) |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Investigator's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation) |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Patient's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation) |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Safety assessments included AEs (including discontinuation due to AEs). |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Safety assessments included dermal assessment (lidocaine group only), skin sensory testing (lidocaine group only), clinical laboratory test results (including urinalysis, vital signs measurements, physical and neurological examinations, and body weight. |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) | 
| Safety assessments included plasma lidocaine concentrations (lidocaine group only). |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84) |