A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

Endo Pharmaceuticals0 sites215 target enrollmentAugust 2004

ConditionsChronic Low Back Pain

InterventionsLidoderm®Placebo Topical Patch

DrugsLidoderm®Placebo Topical Patch

Overview

Phase: Phase 2
Intervention: Lidoderm®
Conditions: Chronic Low Back Pain
Sponsor: Endo Pharmaceuticals
Enrollment: 215
Primary Endpoint: Pain intensity (Question 5 of the BPI)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo.

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

October 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Endo Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Had axial LBP with or without radiation present for at least 3 months as defined as:
•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 radiates 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) prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain).

Exclusion Criteria

•Had spinal stenosis with \> 50% leg pain component
•Had elective surgery scheduled to occur during the 14-week study
•Had a history of one or more back surgeries within 1 year of study entry
•Had severe renal insufficiency (creatinine clearance of \<30mL/min)
•Had moderate or greater hepatic impairment
•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 placebo run-in period
•Had received an epidural steroid/local anesthesia 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

Arms & Interventions

Lidocaine 5% Patch

Lidocaine 5% patch (Lidoderm®,Endo Pharmaceuticals Inc.), 2 patches applied directly to the most painful area of the low back once daily (q24h)

Intervention: Lidoderm®

Placebo Topical Patch

Matching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h)

Intervention: Placebo Topical Patch

Outcomes

Primary Outcomes

Pain intensity (Question 5 of the BPI)

Time Frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)

Secondary Outcomes

Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration(Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84))