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

Sponsor

Endo Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00904020

Collaborator

(none)

107

Enrollment

Locations

Arm

9.7

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postherpetic Neuralgia Diabetic Neuropathy Low Back Pain	Drug: Lidoderm	Phase 4

Study Design

Study Type:

Interventional

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 :

Jun 1, 2002

Actual Primary Completion Date :

Nov 1, 2002

Arms and Interventions

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 Names: Lidocaine patach 5%

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 Names:

Lidocaine patach 5%

Outcome Measures

Primary Outcome Measures

Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6) [Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)]

Secondary Outcome Measures

Pain quality using the Neuropathic Pain Scale (NPS) [Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)]
Investigator and Patient Global Impression of Change [Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)]
Extent of numbness at the site of pain using the Numbness Questionnaire [Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)]
Patient Global Assessment of Pain Relief [Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)]
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 [Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)]
QoL: Pain interference (BPI Question 9) [Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)]
QoL: Patient Global Assessment of Patch Satisfaction [Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Phoenix	Arizona	United States
3	Plantation	Florida	United States
4	Marietta	Georgia	United States
5	Burr Ridge	Illinois	United States
6	Overland Park	Kansas	United States
7	Hackensack	New Jersey	United States
8	Altoona	Pennsylvania	United States
9	Cudahy	Wisconsin	United States
10	Greenfield	Wisconsin	United States
11	West Bend	Wisconsin	United States