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

Official Title: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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”

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.

Intervention(s) in this Clinical Trial

• Drug: Placebo Capsules + Placebo Patch
  • Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
• Drug: Placebo capsules + Lidoderm®
  • Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
• Drug: Gabapentin + Placebo
  • Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
• Drug: Gabapentin + Lidoderm®
  • Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
• Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch
  • Gabapentin 300 mg capsules 1800 mg/day + placebo patch
• Drug: Gabapentin 1800 mg/day + Lidoderm patch

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: placebo capsules + placebo patch
  • Placebo to match lidocaine patch; up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing
• Experimental: placebo capsules + Lidoderm patch (Lidocaine Group)
  • Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing
• Active Comparator: Gabapentin capsules 1800 mg/day + placebo patch
  • Gabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain
• Other: Gabapentin capsules 1800 mg/day + Lidoderm patch
  • Gabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain

Primary Measures

• Average daily pain intensity (BPI Questions 3,4,5, and 6)
  • Time Frame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)
    Safety Issue?: No

Secondary Measures

• Pain Quality Assessment Scale (PQAS)
  • Safety Issue?: Yes
• Investigator and Patient Global Impression of Change
  • Safety Issue?: No
• Allodynia Testing
  • Safety Issue?: No
• QoL; Symptom Checklist, pain interference with QoL
  • Safety Issue?: No
• Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)
  • Safety Issue?: No
• Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination
  • Safety Issue?: Yes

Inclusion Criteria:

• 1. Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor 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 symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
• 4. Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria
• 5. Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration
• 6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral 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 greater than 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 Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Endo Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Sr Director Study Director Endo Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00904202

Study ID Number: EN3220-009

ClinicalTrials.gov Identifier: NCT00904202

Health Authority: United States: Food and Drug Administration