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

Primary Purpose

or Peripheral Nerve Injury (PNI), Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
QUTENZA
Lidocaine
Tramadol
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for or Peripheral Nerve Injury (PNI) focused on measuring Tramadol, QUTENZA, Pre-treatment, Tolerability

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Site 102
  • Site 103
  • Site 101
  • Site 202
  • Site 203
  • Site 201
  • Site 302
  • Site 301
  • Site 402
  • Site 403
  • Site 404
  • Site 401
  • Site 502
  • Site 501
  • Site 603
  • Site 602
  • Site 702
  • Site 701
  • Site 704
  • Site 703

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tramadol

Lidocaine

Arm Description

Tramadol prior to QUTENZA

Lidocaine prior to QUTENZA

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of patch application
Change in pain scores from baseline to subsequent timepoints on the day of patch application
Proportion of subjects using pain medications and dose of pain medication(s) administered
Subject rated tolerability score

Full Information

First Posted
August 11, 2011
Last Updated
April 19, 2018
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01416116
Brief Title
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
Acronym
LIFT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 6, 2011 (Actual)
Primary Completion Date
April 25, 2012 (Actual)
Study Completion Date
April 25, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
or Peripheral Nerve Injury (PNI), Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
Keywords
Tramadol, QUTENZA, Pre-treatment, Tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tramadol
Arm Type
Experimental
Arm Description
Tramadol prior to QUTENZA
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Lidocaine prior to QUTENZA
Intervention Type
Drug
Intervention Name(s)
QUTENZA
Other Intervention Name(s)
capsaicin 8% patch
Intervention Description
topical
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
topical
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
oral
Primary Outcome Measure Information:
Title
The proportion of subjects who tolerate QUTENZA treatment
Description
A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration.
Time Frame
60 minute application period
Secondary Outcome Measure Information:
Title
Duration of patch application
Time Frame
60 minutes
Title
Change in pain scores from baseline to subsequent timepoints on the day of patch application
Time Frame
5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3
Title
Proportion of subjects using pain medications and dose of pain medication(s) administered
Time Frame
day 1-5
Title
Subject rated tolerability score
Time Frame
Baseline to end of study visit, day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Study Manager, Late Phase Clinical Development & Operations
Organizational Affiliation
Astellas Pharma Europe Limited
Official's Role
Study Director
Facility Information:
Facility Name
Site 102
City
Antwerpen
Country
Belgium
Facility Name
Site 103
City
Genk
Country
Belgium
Facility Name
Site 101
City
Roeselare
Country
Belgium
Facility Name
Site 202
City
Hradec Králové
Country
Czechia
Facility Name
Site 203
City
Olomouc
Country
Czechia
Facility Name
Site 201
City
Prague
Country
Czechia
Facility Name
Site 302
City
Aalborg
Country
Denmark
Facility Name
Site 301
City
Aarhus
Country
Denmark
Facility Name
Site 402
City
Cork
Country
Ireland
Facility Name
Site 403
City
Galway
Country
Ireland
Facility Name
Site 404
City
Galway
Country
Ireland
Facility Name
Site 401
City
Limerick
Country
Ireland
Facility Name
Site 502
City
Hamar
Country
Norway
Facility Name
Site 501
City
Skien
Country
Norway
Facility Name
Site 603
City
Kosice
Country
Slovakia
Facility Name
Site 602
City
Martin
Country
Slovakia
Facility Name
Site 702
City
Glasgow
Country
United Kingdom
Facility Name
Site 701
City
Liverpool
Country
United Kingdom
Facility Name
Site 704
City
Manchester
Country
United Kingdom
Facility Name
Site 703
City
Solihull
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=82
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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