Clinical trial NCT00904475: Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Low Back Pain
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint)
timeFrame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Secondary outcomes:
measure: Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)
measure: Pain relief (BPI Question 8)
measure: Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)
measure: Patient and Investigator Global Impression of Pain Relief at Week 6
measure: QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hueytown
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Mill Valley
country: United States
state: California
city: Allentown
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Endo Pharmaceuticals
name: Sr. Director
role: STUDY_DIRECTOR
References: