NCT01416116

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_4

Geographic Reach
7 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2012

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

August 11, 2011

Last Update Submit

April 19, 2018

Conditions

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

Keywords

TramadolQUTENZAPre-treatmentTolerability

Outcome Measures

Primary Outcomes (1)

  • 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.

    60 minute application period

Secondary Outcomes (4)

  • Duration of patch application

    60 minutes

  • Change in pain scores from baseline to subsequent timepoints on the day of patch application

    5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3

  • Proportion of subjects using pain medications and dose of pain medication(s) administered

    day 1-5

  • Subject rated tolerability score

    Baseline to end of study visit, day 7

Study Arms (2)

Tramadol

EXPERIMENTAL

Tramadol prior to QUTENZA

Drug: QUTENZADrug: Tramadol

Lidocaine

EXPERIMENTAL

Lidocaine prior to QUTENZA

Drug: QUTENZADrug: Lidocaine

Interventions

QUTENZADRUG

topical

Also known as: capsaicin 8% patch
LidocaineTramadol
LidocaineDRUG

topical

Lidocaine
TramadolDRUG

oral

Tramadol

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Site 102

Antwerp, Belgium

Location

Site 103

Genk, Belgium

Location

Site 101

Roeselare, Belgium

Location

Site 202

Hradec Králové, Czechia

Location

Site 203

Olomouc, Czechia

Location

Site 201

Prague, Czechia

Location

Site 302

Aalborg, Denmark

Location

Site 301

Aarhus, Denmark

Location

Site 402

Cork, Ireland

Location

Site 403

Galway, Ireland

Location

Site 404

Galway, Ireland

Location

Site 401

Limerick, Ireland

Location

Site 502

Hamar, Norway

Location

Site 501

Skien, Norway

Location

Site 603

Košice, Slovakia

Location

Site 602

Martin, Slovakia

Location

Site 702

Glasgow, United Kingdom

Location

Site 701

Liverpool, United Kingdom

Location

Site 704

Manchester, United Kingdom

Location

Site 703

Solihull, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Peripheral Nerve Injuries

Interventions

CapsaicinTransdermal PatchLidocaineTramadol

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsEquipment and SuppliesAcetanilidesAnilidesAniline CompoundsAminesCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylamines

Study Officials

  • Senior Study Manager, Late Phase Clinical Development & Operations

    Astellas Pharma Europe Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 12, 2011

Study Start

July 6, 2011

Primary Completion

April 25, 2012

Study Completion

April 25, 2012

Last Updated

April 23, 2018

Record last verified: 2018-04

Locations

NO(2)SL(2)GB(4)CZ(3)DK(2)BE(3)IE(4)