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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904020
• Other study ID #: EN3220-008
• Status: Completed
• Phase: Phase 4
• Start date: June 2002

Study information

• Verified date: December 2023
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Diabetic Neuropathies
• Diabetic Neuropathy
• Low Back Pain
• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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