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

Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Low Back Pain

Intervention: Lidoderm® (Drug); Placebo Topical Patch (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
Study Director, Study Director, Affiliation: Endo Pharmaceuticals


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pain intensity (Question 5 of the BPI)

Secondary outcome: Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Key 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).

- Had a daily average pain intensity rating 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 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 Key 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

- Were using a lidocaine-containing product that could not be discontinued during the


- Were using any topical medication applied to the low back region

- Had previously failed treatment with Lidoderm analgesic patch for LBP

- Were taking class 1 anti-arrhythmic drugs (e. g. mexiletine, tocainide)

- Had any other chronic pain condition that, in the opinion of the investigator, would

have interfered with patient assessment of LBP relief

Locations and Contacts

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Carlsbad, California, United States

National City, California, United States

Waterbury, Connecticut, United States

Washington, District of Columbia, United States

Port Orange, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Overland Park, Kansas, United States

Pittsfield, Massachusetts, United States

Burlington, North Carolina, United States

Altoona, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Cordova, Tennessee, United States

San Antonio, Texas, United States

Virginia Beach, Virginia, United States

Additional Information

Starting date: August 2004
Last updated: December 5, 2013

Page last updated: August 23, 2015

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