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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

Primary Purpose

Postherpetic Neuralgia, Diabetic Neuropathy, Low Back Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidoderm
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

(1) Lidoderm

Arm Description

(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.

Outcomes

Primary Outcome Measures

Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)

Secondary Outcome Measures

Pain quality using the Neuropathic Pain Scale (NPS)
Investigator and Patient Global Impression of Change
Extent of numbness at the site of pain using the Numbness Questionnaire
Patient Global Assessment of Pain Relief
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
QoL: Pain interference (BPI Question 9)
QoL: Patient Global Assessment of Patch Satisfaction

Full Information

First Posted
May 15, 2009
Last Updated
February 12, 2010
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00904020
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia, Diabetic Neuropathy, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(1) Lidoderm
Arm Type
Experimental
Arm Description
(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.
Intervention Type
Drug
Intervention Name(s)
Lidoderm
Other Intervention Name(s)
Lidocaine patach 5%
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pain quality using the Neuropathic Pain Scale (NPS)
Time Frame
Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Title
Investigator and Patient Global Impression of Change
Time Frame
Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Title
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)
Title
Patient Global Assessment of Pain Relief
Time Frame
Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Title
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)
Title
QoL: Pain interference (BPI Question 9)
Time Frame
Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Title
QoL: Patient Global Assessment of Patch Satisfaction
Time Frame
Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Plantation
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Burr Ridge
State/Province
Illinois
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Altoona
State/Province
Pennsylvania
Country
United States
City
Cudahy
State/Province
Wisconsin
Country
United States
City
Greenfield
State/Province
Wisconsin
Country
United States
City
West Bend
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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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

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