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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904020
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Endo Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Postherpetic Neuralgia Diabetic Neuropathy Low Back Pain Drug: Lidoderm Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2002
Actual Primary Completion Date : November 2002

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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%


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Pain quality using the Neuropathic Pain Scale (NPS) [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ]
  2. Investigator and Patient Global Impression of Change [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ]
  3. 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) ]
  4. Patient Global Assessment of Pain Relief [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ]
  5. 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) ]
  6. QoL: Pain interference (BPI Question 9) [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ]
  7. QoL: Patient Global Assessment of Patch Satisfaction [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904020


Locations
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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
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Study Director: Study Director Endo Pharmaceuticals
More Information
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Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00904020    
Other Study ID Numbers: EN3220-008
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Neuralgia
Diabetic Neuropathies
Neuralgia, Postherpetic
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action