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

NCT01252160 | Completed Phase 4

• 2 other identifiers: E05-CL-30012009-016457-18
• Study Type: interventional
• Target: 306
• Locations: 15 countries
• Sites: 63

Brief Summary

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.

Conditions

Neuralgia, Postherpetic

Keywords

Neuralgia, Postherpetic; QUTENZA

Outcome Measures

Primary Outcomes (5)

• Adverse events (AEs)

  Throughout the study up to 65 weeks

• Serious adverse events (SAEs)

  Throughout the study up to 65 weeks

• Treatment-emergent adverse events

  Throughout the study up to 65 weeks

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

  Throughout the study up to 65 weeks

• Change in Sensory function

  All visits throughout the study up to 65 weeks

Secondary Outcomes (12)

• Use of concomitant pain medications following each patch application

  Throughout the study up to 65 weeks

• Change from baseline in Vital signs

  All visits throughout the study up to 65 weeks

• Dermal assessment score

  All visits throughout the study up to 65 weeks

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

  All visits throughout the study up to 65 weeks

• Neurological assessment

  All visits throughout the study up to 65 weeks

Study Arms (1)

QUTENZA

EXPERIMENTAL

Cutaneous patch

Drug: QUTENZA

Interventions

QUTENZA DRUG

Cutaneous patch

QUTENZA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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
• 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
• Idiopathic Small Nerve Neuropathy (ISNN): Diagnosis of ISNN based on clinical criteria (e.g. quantitative sensory testing) or skin biopsy
• Neuropathy exclusively or predominantly affecting A-δ (small myelinated) and nociceptive C (unmyelinated) nerve fibres
• Loss of pinprick and temperature sensation in feet
• Other Peripheral Neuropathic Pain (PNP): Adequately characterized PNP based on clinical history and examination existing at the time of screening

You may not qualify if:

• 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)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (64)

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Vienna, 1090, Austria

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Vienna, 1160, Austria

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Antwerp, 2000, Belgium

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Brussels, 1000, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Roeselare, 8800, Belgium

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Brno-Bohunice, 625 00, Czechia

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Plzen-Lochotin, 304 60, Czechia

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Prague, 150 06, Czechia

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Prague, 180 81, Czechia

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Helsinki, 00280, Finland

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Tampere, 33100, Finland

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Boulogne-Billancourt, 92100, France

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Nice, 06002, France

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Paris, 75012, France

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Paris, 75018, France

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Paris, 75651, France

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Saint-Etienne, 42055, France

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Athens, 11528, Greece

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Athens, 54642, Greece

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Pécs, 7623, Hungary

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Cork, Ireland

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Dublin, 9, Ireland

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Chieti, 66100, Italy

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Milan, 20132, Italy

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Naples, 80131, Italy

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Palermo, 90146, Italy

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Pavia, 27100, Italy

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Rimini, 47900, Italy

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Rionero in Vulture, 85028, Italy

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Roma, 00149, Italy

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Taormina, 98039, Italy

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Nieuwegein, 3435, Netherlands

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Zwolle, 8011, Netherlands

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Bydgoszcz, 85-094, Poland

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Katowice, 40-662, Poland

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Lodz, 94-238, Poland

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Warsaw, 00-416, Poland

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Bucharest, Romania

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Timișoara, 300723, Romania

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Bratislava, 85107, Slovakia

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Jesenice, 4270, Slovenia

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Ljubljana, 1000, Slovenia

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Badalona, 08025, Spain

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Barakaldo, 48903, Spain

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Barcelona, 08035, Spain

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Barcelona, 8025, Spain

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Cataluna, 8025, Spain

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Ferrol, 15405, Spain

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Granada, 18014, Spain

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Madrid, 28006, Spain

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Madrid, 28034, Spain

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Málaga, 29010, Spain

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Salamanca, 37007, Spain

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Brighton, BN2 1ES, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Liverpool, L97LJ, United Kingdom

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London, E11BB, United Kingdom

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London, SE1 7EH, United Kingdom

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London, SW10 9NH, United Kingdom

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London, SW17 0QT, United Kingdom

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Solihull, B91 2LJ, United Kingdom

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Related Publications (1)

• Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

  PMID: 36729473 DERIVED

Related Links

• Link to results on EudraCT website
• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Use Central Contact

  Astellas Pharma Europe Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: October 28, 2010
• Primary Completion: September 26, 2013
• Study Completion: September 26, 2013
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

ES (11); BE (5); FI (2); GB (9); IE (2); SL (2); FR (6); NL (2); CZ (4); RO (2); HU (1); PL (4); IT (9); AU (2); GR (2)