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

Phase 4

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Drug: Lidoderm®

• Registration Number: NCT00904475
• Lead Sponsor: Endo Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2003-04
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-12
• Last Update Posted: 2010-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Were currently experiencing moderate/severe pain despite current analgesic treatment
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

1. Had a history of greater than one back surgery, or one back surgery within 3 months of study entry
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-Placebo	Lidoderm®	Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain
1- Lidoderm®	Lidoderm®	Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain

Primary Outcome Measures

Name	Time	Method
Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint)	Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)

Secondary Outcome Measures

Name	Time	Method
Pain relief (BPI Question 8)
Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)
Patient and Investigator Global Impression of Pain Relief at Week 6
QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)
Safety assessments included AEs, discontinuations as a result of AEs, clinical laboratory tests, vital signs, physical examination, plasma lidocaine levels, dermal assessments and sking sensory testing
Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)