Ascending dose of 40 % Lidocaine Gel applied to patients with Postherpetic Neuralgia.

A Phase I/II Pilot Single Ascending Dose, Randomized, Double Blind, Placebo Controlled Study to Evaluate Two Topically Applied 40% Lidocaine Gel Formulations in Patients With Postherpetic Neuralgia (Protocol Number: LID-001)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000143022

Enrollment

Registered

2010-02-12

Start date

2010-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Post Therpetic Neuralgia is the pain that persist after the shingles rash has gone. The purpose of this sutdy is to research the use of Lignocaine in treating this pain. There will be no long term benifits from particpating in this trial as the patients will only recieve one dose of study drug.

Interventions

Ascending dose of 40% Lidocaine gel in two formulations. Cohort 1a and 1b will receive one dose of 0.125 ml of gel applied by hand to the skin Cohort 2a and 2b will recieve one dose of 0.250 mlof gel applied by hand. Cohort 3a and 3b will recieve one dose of 0.500 ml of gel applied by hand.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Male or Female patients with a diagnosis of Herpes Zoster (shingles) with Posthepetic Neuralgia.

Exclusion criteria

Any significant unstable medical condition, allergic reaction or hypersensitivity to Lidocaine.

Outcome results