Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Low Back Pain

In brief

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% compared to placebo in treating moderate to severe chronic LBP.

Key facts

Study ID

NCT00904475

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

102

Starts

2003-04-01

Last updated by the study team

2010-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Hueytown, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Mill Valley, California, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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