A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
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ClinicalTrials.gov Identifier: NCT00904111 |
Recruitment Status :
Completed
First Posted : May 19, 2009
Last Update Posted : December 6, 2013
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Condition or disease | Intervention/treatment | Phase |
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Chronic Low Back Pain | Drug: Lidoderm® Drug: Placebo Topical Patch | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 215 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | August 2004 |
Actual Primary Completion Date : | October 2005 |
Arm | Intervention/treatment |
---|---|
Experimental: 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)
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Drug: Lidoderm®
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Other Name: Lidocaine 5% Patch |
Placebo Comparator: Placebo Topical Patch
Matching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h)
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Drug: Placebo Topical Patch
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch. |
- 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) ]
- Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration [ Time Frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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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
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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 study
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904111
United States, Alabama | |
Birmingham, Alabama, United States | |
United States, Arizona | |
Phoenix, Arizona, United States | |
United States, California | |
Carlsbad, California, United States | |
National City, California, United States | |
United States, Connecticut | |
Waterbury, Connecticut, United States | |
United States, District of Columbia | |
Washington, District of Columbia, United States | |
United States, Florida | |
Port Orange, Florida, United States | |
United States, Georgia | |
Atlanta, Georgia, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Kansas | |
Overland Park, Kansas, United States | |
United States, Massachusetts | |
Pittsfield, Massachusetts, United States | |
United States, North Carolina | |
Burlington, North Carolina, United States | |
United States, Pennsylvania | |
Altoona, Pennsylvania, United States | |
Duncansville, Pennsylvania, United States | |
Philadelphia, Pennsylvania, United States | |
United States, Tennessee | |
Cordova, Tennessee, United States | |
United States, Texas | |
San Antonio, Texas, United States | |
United States, Virginia | |
Virginia Beach, Virginia, United States |
Study Director: | Study Director | Endo Pharmaceuticals |
Responsible Party: | Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00904111 |
Other Study ID Numbers: |
EN3261-001 |
First Posted: | May 19, 2009 Key Record Dates |
Last Update Posted: | December 6, 2013 |
Last Verified: | February 2010 |
Back Pain Low Back Pain Pain Neurologic Manifestations Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |