A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions

Last updated: December 29, 2023
Sponsor: Endo Pharmaceuticals
Overall Status: Completed

Phase

4

Condition

Diabetic Neuropathy

Postherpetic Neuralgia

Carpal Tunnel Syndrome

Treatment

Gabapentin 1800 mg/day + Lidoderm patch

Gabapentin + Placebo

Gabapentin + Lidoderm®

Clinical Study ID

NCT00904202
EN3220-009
  • Ages > 18
  • All Genders

Study Summary

Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathicsensory neuropathy, or other peripheral neuropathy (upon mutual agreement of thesponsor and investigator)
  2. Patients with PHN must have had pain >3 months after rash healing
  3. Patients with DN must have had Type I or II diabetes and painful distal symmetricsensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
  4. Patients with CRPS must have met current IASP (International Association for the Studyof Pain) diagnostic criteria
  5. Patients with carpal tunnel syndrome must have had a diagnosis by combination clinicalneurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostictesting, and daily painful symptoms of at least 3 months' duration
  6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painfulperipheral neuropathy, and daily painful symptoms of at least 3 months' duration
  7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months'duration
  8. Reached an average daily pain rating during the baseline week of pain ratings greaterthan 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI)
  9. Had never received an analgesic regimen that contained lidocaine or gabapentin

Exclusion

Exclusion Criteria:

  1. Had a neurological condition other than that associated with their pain diagnosiswhich, in the opinion of the investigator, would interfere with their ability toparticipate in the study
  2. Were taking a lidocaine-containing product that could not be discontinued whilereceiving lidocaine
  3. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Study Design

Total Participants: 62
Treatment Group(s): 6
Primary Treatment: Gabapentin 1800 mg/day + Lidoderm patch
Phase: 4
Study Start date:
January 01, 2003
Estimated Completion Date:

Connect with a study center

  • Birmingham, Alabama
    United States

    Site Not Available

  • Hueytown, Alabama
    United States

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • Pembroke Pines, Florida
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Rochester, New York
    United States

    Site Not Available

  • Altoona, Pennsylvania
    United States

    Site Not Available

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