Neuropathic Pain Clinical Trial
— PK/PDLidoOfficial title:
Pilot Study: Measurement of Plasma Levels of Lidocaine/Tetracaine and Adverse Effects Derived From a New Topical Formulation for Treatment of Neuropathic Pain
NCT number | NCT06171243 |
Other study ID # | 210821002 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 17, 2023 |
Est. completion date | December 30, 2025 |
Post-herpetic neuralgia (PHN) is the most frequent complications related to herpes zoster, and can persist for months or even years, and require extensive treatment. For this purpose, pharmacological therapies based on tricyclic antidepressants (amitriptyline), central nervous system depressants (pregabalin) and also opioids, have been stablished. However, all the drugs mentioned can cause serious systemic adverse effects that worsen the patient's quality of life. To avoid these complications, topical therapies based on Capsaicin or Lidocaine 5% patches have been developed. However, these treatments have shown dissimilar results in controlling PHN, so a mixed formulation of lidocaine/tetracaine could show better results. For these reasons, the main objective of our work is to evaluate the plasma levels of lidocaine derived from the application of a topical formulation of lidocaine derived from the application of a topical formulation of lidocaine 23%/tetracaine 7% in patients with neuropathic pain.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2025 |
Est. primary completion date | January 4, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Trigeminal neuralgia - Postherpetic neuralgia - Diabetic neuropathy - Chronic postoperative pain - Complex regional pain syndrome - HIV neuropathy - Peripheral neuropathy Exclusion Criteria: - Intravenous lidocaine and/or other treatment interfering with the protocol |
Country | Name | City | State |
---|---|---|---|
Chile | Pontificia Universidad Catolica de Chile | Santiago | Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lidocaine plasmatic levels measured by high performance liquid chromatography | Lidocaine total dose, after using Lidocaine 23%/Tetracaine 7% formulation.10 grams will be applied every 12 hours for a period of 48 hours.
Time "0", where time "0" corresponds to the moment of application of the cream for the first time. Group M1 (Sample N1: 30 min, N2: 2 hours, N3: 4 hours, N4: 12 hours, N5: 26 hours) Group M2 (Sample N1: 45 min, N2: 3 hours, N3: 8 hours, N4: 18 hours, N5: 32 hours) Group M3 (Sample N1: 60 min, N2: 4 hours, N3: 12 hours, N4: 24 hours, N5: 38 hours) Group M4 (Sample N1: 90 min, N2: 5 hours, N3: 16 hours, N4: 30 hours, 44 hours) |
From first application of the cream, which will be applied every 12 hours, to 48 hours after the first application | |
Secondary | Number of Participants with Blood Pressure adverse reactions | Systolic and Diastolic Blood Pressure
Group M1 (Sample N1: 30 min, N2: 2 hours, N3: 4 hours, N4: 12 hours, N5: 26 hours) Group M2 (Sample N1: 45 min, N2: 3 hours, N3: 8 hours, N4: 18 hours, N5: 32 hours) Group M3 (Sample N1: 60 min, N2: 4 hours, N3: 12 hours, N4: 24 hours, N5: 38 hours) Group M4 (Sample N1: 90 min, N2: 5 hours, N3: 16 hours, N4: 30 hours, 44 hours) |
From first application of the cream, which will be applied every 12 hours, to 48 hours after the first application | |
Secondary | Number of Participants with appearance of Heart rate adverse reactions | Heart rate will be measured:
Group M1 (Sample N1: 30 min, N2: 2 hours, N3: 4 hours, N4: 12 hours, N5: 26 hours) Group M2 (Sample N1: 45 min, N2: 3 hours, N3: 8 hours, N4: 18 hours, N5: 32 hours) Group M3 (Sample N1: 60 min, N2: 4 hours, N3: 12 hours, N4: 24 hours, N5: 38 hours) Group M4 (Sample N1: 90 min, N2: 5 hours, N3: 16 hours, N4: 30 hours, 44 hours) |
From first application of the cream, which will be applied every 12 hours, to 48 hours after the first application | |
Secondary | Number of Participants with appearance of Adverse Drug Reactions | Appearance of Adverse Drug Reactions, such as
Group M1 (Sample N1: 30 min, N2: 2 hours, N3: 4 hours, N4: 12 hours, N5: 26 hours) Group M2 (Sample N1: 45 min, N2: 3 hours, N3: 8 hours, N4: 18 hours, N5: 32 hours) Group M3 (Sample N1: 60 min, N2: 4 hours, N3: 12 hours, N4: 24 hours, N5: 38 hours) Group M4 (Sample N1: 90 min, N2: 5 hours, N3: 16 hours, N4: 30 hours, N5: 44 hours) |
From first application of the cream, which will be applied every 12 hours, to 48 hours after the first application |
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