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

Tolerability of QUTENZATM When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study

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.

Study Overview

• Status: Completed
• Conditions: or Peripheral Nerve Injury (PNI); Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
• Intervention / Treatment: Drug: QUTENZA; Drug: Tramadol; Drug: Lidocaine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Site 102
  • Genk, Belgium
    • Site 103
  • Roeselare, Belgium
    • Site 101
• Czechia
  • Hradec Králové, Czechia
    • Site 202
  • Olomouc, Czechia
    • Site 203
  • Prague, Czechia
    • Site 201
• Denmark
  • Aalborg, Denmark
    • Site 302
  • Aarhus, Denmark
    • Site 301
• Ireland
  • Cork, Ireland
    • Site 402
  • Galway, Ireland
    • Site 403
  • Galway, Ireland
    • Site 404
  • Limerick, Ireland
    • Site 401
• Norway
  • Hamar, Norway
    • Site 502
  • Skien, Norway
    • Site 501
• Slovakia
  • Kosice, Slovakia
    • Site 603
  • Martin, Slovakia
    • Site 602
• United Kingdom
  • Glasgow, United Kingdom
    • Site 702
  • Liverpool, United Kingdom
    • Site 701
  • Manchester, United Kingdom
    • Site 704
  • Solihull, United Kingdom
    • Site 703

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tramadol; Tramadol prior to QUTENZA	Drug: QUTENZA; topical; Other Names: capsaicin 8% patch; Drug: Tramadol; oral
Experimental: Lidocaine; Lidocaine prior to QUTENZA	Drug: QUTENZA; topical; Other Names: capsaicin 8% patch; Drug: Lidocaine; topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects who tolerate QUTENZA treatment	A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration.	60 minute application period

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of patch application	60 minutes
Change in pain scores from baseline to subsequent timepoints on the day of patch application	5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3
Proportion of subjects using pain medications and dose of pain medication(s) administered	day 1-5
Subject rated tolerability score	Baseline to end of study visit, day 7

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Senior Study Manager, Late Phase Clinical Development & Operations, Astellas Pharma Europe Limited

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2011
• Primary Completion (Actual): April 25, 2012
• Study Completion (Actual): April 25, 2012

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (Estimate): August 12, 2011

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Tolerability; Tramadol; QUTENZA; Pre-treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Neuralgia; Neuralgia, Postherpetic; Peripheral Nerve Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Dermatologic Agents; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antipruritics; Lidocaine; Tramadol; Capsaicin
• Other Study ID Numbers: QTZ-EC-0002; 2010-023258-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided