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

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ClinicalTrials.gov Identifier: NCT01416116
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : April 23, 2018
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Actual Study Start Date : July 6, 2011
Actual Primary Completion Date : April 25, 2012
Actual Study Completion Date : April 25, 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tramadol
Tramadol prior to QUTENZA
Other Name: capsaicin 8% patch

Drug: Tramadol

Experimental: Lidocaine
Lidocaine prior to QUTENZA
Other Name: capsaicin 8% patch

Drug: Lidocaine

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

Secondary Outcome Measures :
  1. Duration of patch application [ Time Frame: 60 minutes ]
  2. 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 ]
  3. Proportion of subjects using pain medications and dose of pain medication(s) administered [ Time Frame: day 1-5 ]
  4. Subject rated tolerability score [ Time Frame: Baseline to end of study visit, day 7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416116

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Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Senior Study Manager, Late Phase Clinical Development & Operations Astellas Pharma Europe Limited
Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01416116    
Other Study ID Numbers: QTZ-EC-0002
2010-023258-34 ( EudraCT Number )
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
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Neuralgia, Postherpetic
Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Trauma, Nervous System
Wounds and Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Dermatologic Agents