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

NCT ID: NCT01416116

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-06

Study Completion Date

2012-04-25

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tramadol

Tramadol prior to QUTENZA

Group Type EXPERIMENTAL

QUTENZA

Intervention Type DRUG

topical

Tramadol

Intervention Type DRUG

oral

Lidocaine

Lidocaine prior to QUTENZA

Group Type EXPERIMENTAL

QUTENZA

Intervention Type DRUG

topical

Lidocaine

Intervention Type DRUG

topical

Interventions

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QUTENZA

topical

Intervention Type DRUG

Lidocaine

topical

Intervention Type DRUG

Tramadol

oral

Intervention Type DRUG

Other Intervention Names

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capsaicin 8% patch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Senior Study Manager, Late Phase Clinical Development & Operations

Role: STUDY_DIRECTOR

Astellas Pharma Europe Limited

Locations

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Site 102

Antwerp, , Belgium

Site Status

Site 103

Genk, , Belgium

Site Status

Site 101

Roeselare, , Belgium

Site Status

Site 202

Hradec Králové, , Czechia

Site Status

Site 203

Olomouc, , Czechia

Site Status

Site 201

Prague, , Czechia

Site Status

Site 302

Aalborg, , Denmark

Site Status

Site 301

Aarhus, , Denmark

Site Status

Site 402

Cork, , Ireland

Site Status

Site 403

Galway, , Ireland

Site Status

Site 404

Galway, , Ireland

Site Status

Site 401

Limerick, , Ireland

Site Status

Site 502

Hamar, , Norway

Site Status

Site 501

Skien, , Norway

Site Status

Site 603

Košice, , Slovakia

Site Status

Site 602

Martin, , Slovakia

Site Status

Site 702

Glasgow, , United Kingdom

Site Status

Site 701

Liverpool, , United Kingdom

Site Status

Site 704

Manchester, , United Kingdom

Site Status

Site 703

Solihull, , United Kingdom

Site Status

Countries

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Belgium Czechia Denmark Ireland Norway Slovakia United Kingdom

Related Links

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https://www.astellasclinicalstudyresults.com/study.aspx?ID=82

Link to results on Astellas Clinical Study Results website

Other Identifiers

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2010-023258-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

QTZ-EC-0002

Identifier Type: -

Identifier Source: org_study_id

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