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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904020
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Postherpetic Neuralgia
Diabetic Neuropathy
Low Back Pain
Drug: Lidoderm
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain quality using the Neuropathic Pain Scale (NPS) [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ] [ Designated as safety issue: No ]
  • Investigator and Patient Global Impression of Change [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ] [ Designated as 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) ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Pain Relief [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ] [ Designated as 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) ] [ Designated as safety issue: Yes ]
  • QoL: Pain interference (BPI Question 9) [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ] [ Designated as safety issue: No ]
  • QoL: Patient Global Assessment of Patch Satisfaction [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: June 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Name: Lidocaine patach 5%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904020

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Florida
Plantation, Florida, United States
United States, Georgia
Marietta, Georgia, United States
United States, Illinois
Burr Ridge, Illinois, United States
United States, Kansas
Overland Park, Kansas, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
United States, Wisconsin
Cudahy, Wisconsin, United States
Greenfield, Wisconsin, United States
West Bend, Wisconsin, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Study Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00904020     History of Changes
Other Study ID Numbers: EN3220-008
Study First Received: May 15, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neuralgia
Diabetic Neuropathies
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014