Clinical trial NCT00904020: A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postherpetic Neuralgia
Diabetic Neuropathy
Low Back Pain
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Secondary outcomes:
measure: Pain quality using the Neuropathic Pain Scale (NPS)
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
measure: Investigator and Patient Global Impression of Change
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
measure: Extent of numbness at the site of pain using the Numbness Questionnaire
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
measure: Patient Global Assessment of Pain Relief
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
measure: 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
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
measure: QoL: Pain interference (BPI Question 9)
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
measure: QoL: Patient Global Assessment of Patch Satisfaction
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Plantation
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Burr Ridge
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Hackensack
country: United States
state: New Jersey
city: Altoona
country: United States
state: Pennsylvania
city: Cudahy
country: United States
state: Wisconsin
city: Greenfield
country: United States
state: Wisconsin
city: West Bend
country: United States
state: Wisconsin
Study officials:
affiliation: Endo Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: