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

Endo Pharmaceuticals

Status and phase

Terminated

Phase 4

Conditions

Chronic Low Back Pain

Treatments

Drug: Celecoxib

Drug: Lidoderm®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00904397

EN3220-013

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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