Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
NCT ID: NCT00904475
Last Updated: 2010-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2003-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1- Lidoderm®
Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain
Lidoderm®
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
2-Placebo
Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain
Lidoderm®
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
Interventions
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Lidoderm®
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
Lidoderm®
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Had daily moderate-to-severe LBP for at least 3 months duration
3. Had a mean daily pain intensity score of \>6 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week
Exclusion Criteria
2. Had severe spinal stenosis
3. Had chronic back pain of \>12 months duration with an undefined spinal diagnosis
4. Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.)
5. Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
6. Had received trigger point injections within 2 weeks prior to study entry
7. Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry
8. Were taking a lidocaine-containing product that could not be discontinued while receiving study medication
9. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
10. Had received Lidoderm for LBP in the past
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Endo Pharmaceuticals
Principal Investigators
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Sr. Director
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Hueytown, Alabama, United States
Phoenix, Arizona, United States
Mill Valley, California, United States
Allentown, Pennsylvania, United States
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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EN3220-011
Identifier Type: -
Identifier Source: org_study_id
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