Clinical trial NCT00904202: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postherpetic Neuralgia
Diabetic Neuropathy
Complex Regional Pain Syndrome
Carpal Tunnel Syndrome
HIV Neuropathy
Idiopathic Sensory Neuropathy
Peripheral Neuropathy
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Average daily pain intensity (BPI Questions 3,4,5, and 6)
timeFrame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)
Secondary outcomes:
measure: Pain Quality Assessment Scale (PQAS)
measure: Investigator and Patient Global Impression of Change
measure: Allodynia Testing
measure: QoL; Symptom Checklist, pain interference with QoL
measure: Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)
measure: Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hueytown
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Pembroke Pines
country: United States
state: Florida
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Altoona
country: United States
state: Pennsylvania
Study officials:
affiliation: Endo Pharmaceuticals
name: Sr Director
role: STUDY_DIRECTOR
References: