Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch (LIFT)

Astellas

Status and phase: Completed; Phase 4

Conditions: Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN); or Peripheral Nerve Injury (PNI)

Treatments: Drug: Tramadol; Drug: Lidocaine; Drug: QUTENZA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01416116

QTZ-EC-0002

2010-023258-34 (EudraCT Number)

Details and patient eligibility

About

The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.

Full description

All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.

Enrollment: 122 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury
• Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit
• Intact, non-irritated, dry skin over the painful area(s) to be treated

Exclusion criteria

• Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury
• Past or current history of Type I or Type II diabetes mellitus
• Active malignancy or treatment for malignancy within a year prior to the Treatment Visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Tramadol

Experimental group

Description:

Tramadol prior to QUTENZA

Treatment:

Drug: QUTENZA

Drug: Tramadol

Lidocaine

Experimental group

Description:

Lidocaine prior to QUTENZA

Treatment:

Drug: QUTENZA

Drug: Lidocaine