Status:
COMPLETED
Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% ...
Eligibility Criteria
Inclusion
- Were currently experiencing moderate/severe pain despite current analgesic treatment
- Had daily moderate-to-severe LBP for at least 3 months duration
- 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
- Had a history of greater than one back surgery, or one back surgery within 3 months of study entry
- Had severe spinal stenosis
- Had chronic back pain of \>12 months duration with an undefined spinal diagnosis
- Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.)
- Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
- Had received trigger point injections within 2 weeks prior to study entry
- Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry
- Were taking a lidocaine-containing product that could not be discontinued while receiving study medication
- Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
- Had received Lidoderm for LBP in the past
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00904475
Start Date
April 1 2003
Last Update
February 15 2010
Active Locations (6)
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1
Birmingham, Alabama, United States
2
Hueytown, Alabama, United States
3
Phoenix, Arizona, United States
4
Mill Valley, California, United States