NCT00904020

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

May 15, 2009

Last Update Submit

December 29, 2023

Conditions

Postherpetic NeuralgiaDiabetic NeuropathyLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Study Arms (1)

(1) Lidoderm

EXPERIMENTAL

(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

Interventions

LidodermDRUG

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.

Also known as: Lidocaine patach 5%
(1) Lidoderm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Plantation, Florida, United States

Location

Unknown Facility

Marietta, Georgia, United States

Location

Unknown Facility

Burr Ridge, Illinois, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

Altoona, Pennsylvania, United States

Location

Unknown Facility

Cudahy, Wisconsin, United States

Location

Unknown Facility

Greenfield, Wisconsin, United States

Location

Unknown Facility

West Bend, Wisconsin, United States

Location

MeSH Terms

Conditions

Neuralgia, PostherpeticDiabetic NeuropathiesLow Back Pain

Interventions

Lidoderm

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBack Pain

Study Officials

  • Study Director

    Endo Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 19, 2009

Study Start

June 1, 2002

Primary Completion

November 1, 2002

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

US(11)