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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01416116
First received: August 11, 2011
Last updated: March 4, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
or Peripheral Nerve Injury (PNI)
Drug: QUTENZA
Drug: Lidocaine
Drug: Tramadol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The proportion of subjects who tolerate QUTENZA treatment [ Time Frame: 60 minute application period ] [ Designated as safety issue: No ]
    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 [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects using pain medications and dose of pain medication(s) administered [ Time Frame: day 1-5 ] [ Designated as safety issue: No ]
  • Subject rated tolerability score [ Time Frame: Baseline to end of study visit, day 7 ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tramadol
Tramadol prior to QUTENZA
Drug: QUTENZA
topical
Other Name: capsaicin 8% patch
Drug: Tramadol
oral
Experimental: Lidocaine
Lidocaine prior to QUTENZA
Drug: QUTENZA
topical
Other Name: capsaicin 8% patch
Drug: Lidocaine
topical

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416116

Locations
Belgium
Site 102
Antwerpen, Belgium
Site 103
Genk, Belgium
Site 101
Roeselare, Belgium
Czech Republic
Site 202
Hradec Králové, Czech Republic
Site 203
Olomouc, Czech Republic
Site 201
Prague, Czech Republic
Denmark
Site 302
Aalborg, Denmark
Site 301
Aarhus, Denmark
Ireland
Site 402
Cork, Ireland
Site 403
Galway, Ireland
Site 404
Galway, Ireland
Site 401
Limerick, Ireland
Norway
Site 502
Hamar, Norway
Site 501
Skien, Norway
Slovakia
Site 603
Kosice, Slovakia
Site 602
Martin, Slovakia
United Kingdom
Site 702
Glasgow, United Kingdom
Site 701
Liverpool, United Kingdom
Site 704
Manchester, United Kingdom
Site 703
Solihull, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Senior Study Manager, Late Phase Clinical Development & Operations Astellas Pharma Europe Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01416116     History of Changes
Other Study ID Numbers: QTZ-EC-0002, 2010-023258-34
Study First Received: August 11, 2011
Last Updated: March 4, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Slovakia: State Institute for Drug Control

Keywords provided by Astellas Pharma Inc:
QUTENZA
Pre-treatment
Tramadol
Tolerability

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Peripheral Nerve Injuries
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trauma, Nervous System
Capsaicin
Lidocaine
Tramadol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Central Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 27, 2014