Topical Lidocaine Patch in Low Back Pain

NCT00904540 | Completed Phase 4

• 1 other identifier: EN3220-006
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 7

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.

Conditions

Acute and Chronic Non-radicular LBP

Outcome Measures

Primary Outcomes (1)

• Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)

Secondary Outcomes (4)

• Mean change from baseline to Week 6 in average pain intensity (Question 5 of the BPI)

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)

• Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)

• 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

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)

• Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments.

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)

Study Arms (1)

Lidoderm®

EXPERIMENTAL

Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain

Drug: Lidoderm®

Interventions

Lidoderm® DRUG

Patients participated in a 6-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Patients were stratified into the following groups at enrollment: acute (\<6 weeks) LBP, subacute (6 weeks to \<3 months) LBP, short-term chronic (3 months to 12 months, inclusive) LBP, and long-term chronic (\>12 months LBP)

Also known as: Lidocaine patch 5%

Lidoderm®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (7)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Mill Valley, California, United States

Location

Unknown Facility

Weston, Florida, United States

Location

Unknown Facility

Bethpage, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Allentown, Pennsylvania, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

MeSH Terms

Interventions

Lidoderm

Study Officials

• Study Director

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 19, 2009
• Study Start: March 1, 2002
• Primary Completion: October 1, 2002
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

US (7)