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