A Phase 4 interventional study of Lidoderm in Postherpetic Neuralgia, Diabetic Neuropathy and Low Back Pain, sponsored by Endo Pharmaceuticals. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-02.
Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 4, Interventional, and Treatment
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.
196 studies on the registry are indexed under Neuralgia, Postherpetic; 28 are open to participants now.
This study's enrollment of 107 is above the median of 94 across 162 interventional studies indexed under Neuralgia, Postherpetic.
Browse Neuralgia, Postherpetic studies →Endo Pharmaceuticals is the lead sponsor of 99 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(1) 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.
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.
Also known as: Lidocaine patach 5%
Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Pain quality using the Neuropathic Pain Scale (NPS)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Investigator and Patient Global Impression of Change
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Extent of numbness at the site of pain using the Numbness Questionnaire
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Patient Global Assessment of Pain Relief
Time frame: 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
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Pain interference (BPI Question 9)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Patient Global Assessment of Patch Satisfaction
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidoderm