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NCT Number: NCT01416116

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

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.

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Key information

Conditions

or Peripheral Nerve Injury (PNI) Nervous System Diseases Neuromuscular Diseases Peripheral Nerve Injuries Peripheral Nervous System Diseases Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) Trauma, Nervous System Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Site 102, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qutenza

Drug

topical

Other names: capsaicin 8% patch

Lidocaine

Drug

topical

Tramadol

Drug

oral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Acronym: LIFT

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 12, 2011
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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