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

Chronic Low Back Pain Clinical Trial

Official title:

A Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904475
• Other study ID #: EN3220-011
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2009
• Last updated: February 12, 2010
• Start date: April 2003

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)			No
Secondary	Pain relief (BPI Question 8)			No
Secondary	Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)			No
Secondary	Patient and Investigator Global Impression of Pain Relief at Week 6			No
Secondary	QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)			No
Secondary	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			Yes