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CompletedNCT00904540Updated Jan 2, 2024

Topical Lidocaine Patch in Low Back Pain

A Phase 4 interventional study of Lidoderm® in Acute and Chronic Non-radicular LBP, sponsored by Endo Pharmaceuticals. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-02.

Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
131
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute and Chronic Non-radicular LBP
03

In context

Lead sponsor

Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.

Browse Endo Pharmaceuticals studies →All Keenova Therapeutics plc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 /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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
131 participants (actual)

Study arms

  • Experimental
    Lidoderm®

    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

  • DrugLidoderm®

    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%

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

07

Study locations

7 sites
  • Phoenix, Arizona, United States
  • Mill Valley, California, United States
  • Weston, Florida, United States
  • Bethpage, New York, United States
  • Charlotte, North Carolina, United States
  • Allentown, Pennsylvania, United States
  • Madison, Wisconsin, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2002 and a primary completion of Oct 2002. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2009
First posted
May 19, 2009
Start
Mar 2002
Primary completionActual
Oct 2002
Last update
Jan 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00904540
Lead sponsor
Endo Pharmaceuticals
First posted
May 19, 2009
Start date
Mar 2002
Primary completion
Oct 2002
Last update
Jan 2, 2024

Study contacts

Study Director
study director · Endo Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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