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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

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

NCT ID

NCT00904020

First Posted

May 15, 2009

Last Updated

February 12, 2010

Sponsor

Endo Pharmaceuticals

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