A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain

Official Title: “A Prospective, Open-Label, Multicenter Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain”

Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.

Intervention(s) in this Clinical Trial

• Drug: Lidoderm
  • Patients participated in a 2-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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: (1) Lidoderm
  • (1) 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.

Primary Measures

• Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)
  • Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
    Safety Issue?: No

Secondary Measures

• Pain quality using the Neuropathic Pain Scale (NPS)
  • Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
    Safety Issue?: No
• Investigator and Patient Global Impression of Change
  • Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
    Safety Issue?: No
• Extent of numbness at the site of pain using the Numbness Questionnaire
  • Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
    Safety Issue?: No
• Patient Global Assessment of Pain Relief
  • Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
    Safety Issue?: No
• Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments
  • Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
    Safety Issue?: Yes
• QoL: Pain interference (BPI Question 9)
  • Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
    Safety Issue?: No
• QoL: Patient Global Assessment of Patch Satisfaction
  • Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
    Safety Issue?: No

Inclusion Criteria:

• Were currently receiving an analgesic regimen that contained gabapentin
• Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
• Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of >4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain
• Inventory [BPI] within 24 hours prior to the screening visit
• For diabetic patients, had a hemoglobin A1c level <0.13 (normal range, 0.047-0.064)

Exclusion Criteria:

• Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
• Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
• Had received trigger point injections within 14 days 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)

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

Study Director Study Director Endo Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00904020

Study ID Number: EN3220-008

ClinicalTrials.gov Identifier: NCT00904020

Health Authority: United States: Food and Drug Administration