Diabetic Neuropathy, Low Back Pain, Postherpetic Neuralgia
Conditions
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.
Interventions
DRUGLidoderm
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.
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| Pain quality using the Neuropathic Pain Scale (NPS) | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
| QoL: Pain interference (BPI Question 9) | Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14) |
| QoL: Patient Global Assessment of Patch Satisfaction | 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) |
Countries
United States
Outcome results
None listed