A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions

Carpal Tunnel Syndrome Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904202
• Other study ID #: EN3220-009
• Status: Completed
• Phase: Phase 4
• Start date: January 2003

Study information

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

Clinical Trial Summary

Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator)

2. Patients with PHN must have had pain >3 months after rash healing

3. Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities

4. Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria

5. Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration

6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration

7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration

8. Reached an average daily pain rating during the baseline week of pain ratings greater than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI)

9. Had never received an analgesic regimen that contained lidocaine or gabapentin

Exclusion Criteria:

1. Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study

2. Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine

3. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Diabetic Neuropathies
• Diabetic Neuropathy
• HIV Neuropathy
• Idiopathic Sensory Neuropathy
• Neuralgia
• Neuralgia, Postherpetic
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Postherpetic Neuralgia
• Reflex Sympathetic Dystrophy
• Syndrome

Intervention

Drug:
• Placebo Capsules + Placebo Patch
Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
• Placebo capsules + Lidoderm®
Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
• Gabapentin + Placebo
Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
• Gabapentin + Lidoderm®
Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
• Gabapentin 300 mg capsules 1800 mg/day + placebo patch
Gabapentin 300 mg capsules 1800 mg/day + placebo patch
• Gabapentin 1800 mg/day + Lidoderm patch

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 (BPI Questions 3,4,5, and 6)		Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)
Secondary	Pain Quality Assessment Scale (PQAS)
Secondary	Investigator and Patient Global Impression of Change
Secondary	Allodynia Testing
Secondary	QoL; Symptom Checklist, pain interference with QoL
Secondary	Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)
Secondary	Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination