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Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuralgia, Postherpetic

Intervention: QUTENZA (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Europe Ltd.


In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.

Clinical Details

Official title: A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Adverse events (AEs)

Serious adverse events (SAEs)

Treatment-emergent adverse events

Proportion of subjects who prematurely terminate from the study due to an AE

Change in Sensory function

Secondary outcome:

Use of concomitant pain medications following each patch application

Change from baseline in Vital signs

Dermal assessment score

The proportion of subjects completing at least 90% of the intended patch application duration

Neurological assessment

Brief Pain Inventory (BPI)

Patient Global Impression of Change (PGIC)

European Quality of life questionnaire in 5 Dimensions (EQ5D)

Hospital Anxiety and Depression Score (HADS)

Work Productivity and Activity Impairment Questionnaire: Neuropathic Pain (WPAI:NP)

Self-Assessment of Treatment (SAT) questionnaire

Change in use of concomitant pain medications

Detailed description: The rationale for the current study is to evaluate the safety of repeated QUTENZA applications, including the effect of QUTENZA on sensory function in subjects diagnosed with different types of Peripheral Neuropathic Pain (PNP). In order to adequately assess the long-term safety QUTENZA in well defined patient populations the current study will enroll a minimum of 100 patients each with HIV-Associated Neuropathy (HIV-AN) and Postherpetic Neuralgia (PHN).


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


Common Inclusion Criteria:

- Be in good health as determined by the investigator

- Average pain score >=4 during screening period (using the average reported pain from

the Brief Pain Inventory [BPI])

- Intact, non-irritated, dry skin over the painful area(s) to be treated

- All females of child bearing potential must be willing to use effective methods of

birth control during the study and for 30 days following study termination

- Be willing and able to comply with protocol requirements for the duration of study

participation Population-specific Inclusion Criteria:

- All subjects must meet one (and only one) of the Population-Specific Inclusion

Criteria for PHN, HIV-AN, PNI or ISNN or have adequately characterized PNP based on clinical history and examination.

- Postherpetic Neuralgia (PHN): Prior diagnosis of PHN with pain persisting at

least 3 months since shingles vesicle crusting, documented by the primary treating physician or investigator

- Or

- Painful HIV-Associated Neuropathy (HIV-AN): Presence of HIV-AN existing for a

minimum of 3 months, confirmed using the Brief Peripheral Neuropathy Screen (BPNS) at the time of study entry

- Or

- Peripheral Neuropathic Injury (PNI): Diagnosis of Post-traumatic Peripheral

Neuropathic Pain syndrome, including post-surgical neuropathic pain, neuropathic pain due to peripheral nerve injury, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event

- Or

- Idiopathic Small Nerve Neuropathy (ISNN): Diagnosis of ISNN based on clinical

criteria (e. g. quantitative sensory testing) or skin biopsy 1. Neuropathy exclusively or predominantly affecting A-δ (small myelinated) and nociceptive C (unmyelinated) nerve fibres 2. Loss of pinprick and temperature sensation in feet

- Or

- Other Peripheral Neuropathic Pain (PNP): Adequately characterized PNP based on

clinical history and examination existing at the time of screening Exclusion Criteria:

- Any prior receipt of QUTENZA open label or blinded study patches

- Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80

mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application visit

- Lack of an effective pain medication strategy for the subject, such as unwillingness

to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oxycodone or other analgesic, as judged by the investigator

- Active substance abuse or history of chronic substance abuse within 1 year prior to

enrolment or prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator

- Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs,

menthol, methyl salicylate, local anesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application visit

- Current use of any investigational agent (excluding antiretrovirals in Phase 3

evaluation to treat HIV infection)

- Unstable or poorly controlled hypertension or a recent history of a cardiovascular

event which, in the opinion of the investigator, would put the patient at risk of adverse cardiovascular reactions related to the patch application procedure

- Evidence of another contributing cause for peripheral neuropathy, and/or treatment

within 90 days prior to screening visit with any drug that may have contributed to the sensory neuropathy

- Past or current history of Type I or Type II diabetes mellitus

- Current psychotic disorders

- Clinically significant abnormal ECG at screening

- Hypersensitivity to capsaicin (i. e., chilli peppers or Over-the-counter [OTC]

capsaicin products), any QUTENZA excipients, local anesthetics, oxycodone, hydrocodone, or adhesives

- Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or

pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events

- Significant pain of an aetiology other than painful HIV-AN, PHN, PNI, ISNN or other

adequately characterized PNP for example, compression-related neuropathies (e. g., spinal stenosis), fibromyalgia or arthritis

- Posttraumatic neuropathic pain due to Complex Regional Pain Syndrome (CRPS, Type I)

- Active malignancy or history of malignancy during the past 5 years (a history of

squamous cell carcinoma or a basal cell carcinoma not involving the area to be treated is allowed)

- Evidence of cognitive impairment including dementia that may interfere with subject's

ability to complete study evaluations and recall pain levels in the past 24 hours

- Planned elective surgery during the trial

- Neuropathic pain areas located only on the face, above the hairline of the scalp,

and/or in proximity to mucous membranes

- Female subjects of child-bearing potential with a positive serum or urine pregnancy

test prior to treatment

Locations and Contacts

Vienna 1090, Austria

Vienna 1160, Austria

Antwerpen 2000, Belgium

Brussels 1000, Belgium

Edegem 2650, Belgium

Genk 3600, Belgium

Roeselare 8800, Belgium

Brno-Bohunice 625 00, Czech Republic

Plzen-Lochotin 304 60, Czech Republic

Prague 5 150 06, Czech Republic

Prague 180 81, Czech Republic

Helsinki 00280, Finland

Tampere 33100, Finland

Boulogne Billancourt 92100, France

Nice 06002, France

Paris Cedex 13 75651, France

Paris 75012, France

Paris 75018, France

Saint - Etienne Cedex 2 42055, France

Athens 54642, Greece

Athens 11528, Greece

Pecs 7623, Hungary

Cork, Ireland

Dublin 9, Ireland

Chieti 66100, Italy

Milan 20132, Italy

Naples 80131, Italy

Palermo 90146, Italy

Pavia 27100, Italy

Rimini 47900, Italy

Rionero in Vulture 85028, Italy

Roma 00149, Italy

Taormina 98039, Italy

Nieuwegein 3435, Netherlands

Zwolle 8011, Netherlands

Bydgoszcz 85-094, Poland

Katowice 40-662, Poland

Lodz 94-238, Poland

Warsawa 00-416, Poland

Bucuresti, Romania

Timisoara 300723, Romania

Bratislava 85107, Slovakia

Jesenice 4270, Slovenia

Ljubljana 1000, Slovenia

Badalona 08025, Spain

Barakaldo 48903, Spain

Barcelona 08035, Spain

Barcelona 8025, Spain

Cataluna 8025, Spain

Ferrol 15405, Spain

Granada 18014, Spain

Madrid 28034, Spain

Madrid 28006, Spain

Malaga 29010, Spain

Salamanca 37007, Spain

Brighton BN2 1ES, United Kingdom

Edinburgh EH4 2XU, United Kingdom

Glasgow G12 0YN, United Kingdom

Liverpool L97LJ, United Kingdom

London E11BB, United Kingdom

London SE1 7EH, United Kingdom

London SW10 9NH, United Kingdom

London SW17 0QT, United Kingdom

Solihull B91 2LJ, United Kingdom

Additional Information

Link to Results on JAPIC - enter 140608 in the JapicCTI-RNo. field

Link to results on EudraCT

Starting date: October 2010
Last updated: June 12, 2015

Page last updated: August 20, 2015

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