A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
1 other identifier
interventional
215
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 19, 2009
CompletedDecember 6, 2013
February 1, 2010
1.2 years
May 15, 2009
December 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity (Question 5 of the BPI)
Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
Secondary Outcomes (1)
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)
Study Arms (2)
Lidocaine 5% Patch
EXPERIMENTALLidocaine 5% patch (Lidoderm®,Endo Pharmaceuticals Inc.), 2 patches applied directly to the most painful area of the low back once daily (q24h)
Placebo Topical Patch
PLACEBO COMPARATORMatching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h)
Interventions
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Carlsbad, California, United States
Unknown Facility
National City, California, United States
Unknown Facility
Waterbury, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Port Orange, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Pittsfield, Massachusetts, United States
Unknown Facility
Burlington, North Carolina, United States
Unknown Facility
Altoona, Pennsylvania, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Cordova, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Virginia Beach, Virginia, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Endo Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 19, 2009
Study Start
August 1, 2004
Primary Completion
October 1, 2005
Last Updated
December 6, 2013
Record last verified: 2010-02