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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 | Clinical Trials | Clareo Health

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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

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

NCT00904020•Endo Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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)

Locations (11)

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Plantation, Florida, United States

Marietta, Georgia, United States

Burr Ridge, Illinois, United States

Overland Park, Kansas, United States

Hackensack, New Jersey, United States

Altoona, Pennsylvania, United States

Cudahy, Wisconsin, United States

Greenfield, Wisconsin, United States

Key Dates

Start Date

June 1, 2002

Primary Completion Date

November 1, 2002

Last Updated

January 2, 2024

Enrollment

107

ACTUAL participants

Conditions

Postherpetic NeuralgiaDiabetic NeuropathyLow Back Pain

Interventions

Lidoderm

DRUG

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

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Discogenic Low Back Pain

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RECRUITINGNA

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

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Chronic Low Back Pain

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

Time to BBVNA Relief

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Pilates Exercises on Nonspecific Low Back Pain in Postnatal Women