Clinical trial NCT00904540: Topical Lidocaine Patch in Low Back Pain
Official title: Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute and Chronic Non-radicular LBP
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP.


Eligibility criteria: Inclusion Criteria:

* Non-radicular LBP pain for

  ≤12 months (non-radicular defined as LBP that does not radiate below the mid-buttock and with no sensory symptoms in the leg)
* Had LBP as the primary source of pain. Patients may have had mild to moderate spinal stenosis and no radicular symptoms
* Had an average daily pain intensity score of \>4 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) within 24 hours prior to the screening visit.
* Had a normal neurological examination, including:

  * Motor strength
  * Sensory testing (light touch, pinprick, and vibration)
  * Deep tendon reflexes

Patients were eligible for participation in the long-term chronic (\>12 months) group of the study if they also:

* Had LBP for greater than one year. Patients may have had any of the following: lumbar degenerative disc disease, internal disc disruption, mild-to-severe spinal stenosis, degenerative scoliosis and spondylolisthesis, facet arthropathy

Exclusion Criteria:

* Had a history of greater than one back surgery or one back surgery within 3 months of study entry
* Had severe spinal stenosis and radicular symptoms
* Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief
* 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 Botox Injections within 3 months prior to study entry
* Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
* Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Patients were excluded from participation in the long-term chronic (\>12 months) group if they also:

* Had an undefined spinal diagnosis
* Had a history of lumbar spine surgery within 6 months prior to study entry

Primary outcomes:
measure: Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2
timeFrame: Visits - 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 6 in average pain intensity (Question 5 of the BPI)
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
measure: Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
measure: QOL: change from baseline to Week 2 to Week 6 in Question 9 of the BPI, in Beck Depression Inventory Questionnaire, and the Patient and Investigator Global Assessment of Patch Satisfaction and Pain Relief
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
measure: Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments.
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Mill Valley
country: United States
state: California
city: Weston
country: United States
state: Florida
city: Bethpage
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Allentown
country: United States
state: Pennsylvania
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Endo Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: