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Topical Lidocaine Patch in Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904540
First received: May 15, 2009
Last updated: February 8, 2010
Last verified: February 2010

May 15, 2009
February 8, 2010
March 2002
October 2002   (final data collection date for primary outcome measure)
Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2 [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00904540 on ClinicalTrials.gov Archive Site
  • Mean change from baseline to Week 6 in average pain intensity (Question 5 of the BPI) [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
  • Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
  • Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments. [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Topical Lidocaine Patch in Low Back Pain
Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute and Chronic Non-radicular LBP
Drug: Lidoderm®
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)
Other Name: Lidocaine patch 5%
Experimental: Lidoderm®
Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain
Intervention: Drug: Lidoderm®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
Not Provided
October 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00904540
EN3220-006
Not Provided
Sr Director, Clinical R & D, Endo Pharmaceuticals, Inc.
Endo Pharmaceuticals
Not Provided
Study Director: Study Director Endo Pharmaceuticals
Endo Pharmaceuticals
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP