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

Phase 4

Completed

• Conditions: or Peripheral Nerve Injury (PNI); Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
• Interventions: Drug: QUTENZA; Drug: Tramadol; Drug: Lidocaine

• Registration Number: NCT01416116
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-07-06
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2012-04-25
• Study Completion: 2012-04-25
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol	Tramadol	Tramadol prior to QUTENZA
Tramadol	QUTENZA	Tramadol prior to QUTENZA
Lidocaine	QUTENZA	Lidocaine prior to QUTENZA
Lidocaine	Lidocaine	Lidocaine prior to QUTENZA

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who tolerate QUTENZA treatment	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

Name	Time	Method
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

Trial Locations

Locations (20)

Site 102; 🇧🇪 Antwerpen, Belgium

Site 103; 🇧🇪 Genk, Belgium

Site 101; 🇧🇪 Roeselare, Belgium

Site 202; 🇨🇿 Hradec Králové, Czechia

Site 404; 🇮🇪 Galway, Ireland

Site 702; 🇬🇧 Glasgow, United Kingdom

Site 302; 🇩🇰 Aalborg, Denmark

Site 301; 🇩🇰 Aarhus, Denmark

Site 703; 🇬🇧 Solihull, United Kingdom

Site 203; 🇨🇿 Olomouc, Czechia

Site 201; 🇨🇿 Prague, Czechia

Site 603; 🇸🇰 Kosice, Slovakia

Site 402; 🇮🇪 Cork, Ireland

Site 701; 🇬🇧 Liverpool, United Kingdom

Site 704; 🇬🇧 Manchester, United Kingdom

Site 401; 🇮🇪 Limerick, Ireland

Site 501; 🇳🇴 Skien, Norway

Site 403; 🇮🇪 Galway, Ireland

Site 502; 🇳🇴 Hamar, Norway

Site 602; 🇸🇰 Martin, Slovakia