Clinical trial NCT01252160: Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage
Official title: A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuralgia, Postherpetic
Keywords: Neuralgia, Postherpetic
QUTENZA
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Throughout the study up to 65 weeks
measure: Serious adverse events (SAEs)
timeFrame: Throughout the study up to 65 weeks
measure: Treatment-emergent adverse events
timeFrame: Throughout the study up to 65 weeks
measure: Proportion of subjects who prematurely terminate from the study due to an AE
timeFrame: Throughout the study up to 65 weeks
measure: Change in Sensory function
timeFrame: All visits throughout the study up to 65 weeks
Secondary outcomes:
measure: Use of concomitant pain medications following each patch application
timeFrame: Throughout the study up to 65 weeks
measure: Change from baseline in Vital signs
timeFrame: All visits throughout the study up to 65 weeks
measure: Dermal assessment score
timeFrame: All visits throughout the study up to 65 weeks
measure: The proportion of subjects completing at least 90% of the intended patch application duration
timeFrame: All visits throughout the study up to 65 weeks
measure: Neurological assessment
timeFrame: All visits throughout the study up to 65 weeks
measure: Brief Pain Inventory (BPI)
timeFrame: Throughout the study up to 65 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: All visits throughout the study except the first patch application visit up to 65 weeks
measure: European Quality of life questionnaire in 5 Dimensions (EQ5D)
timeFrame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
measure: Hospital Anxiety and Depression Score (HADS)
timeFrame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
measure: Work Productivity and Activity Impairment Questionnaire: Neuropathic Pain (WPAI:NP)
timeFrame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
measure: Self-Assessment of Treatment (SAT) questionnaire
timeFrame: At the Week 26 visit and planned or early termination visit no later than week 65
measure: Change in use of concomitant pain medications
timeFrame: Throughout the study up to 65 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
city: Vienna
country: Austria
city: Antwerpen
country: Belgium
city: Brussels
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Roeselare
country: Belgium
city: Brno-Bohunice
country: Czechia
city: Plzen-Lochotin
country: Czechia
city: Prague 5
country: Czechia
city: Prague
country: Czechia
city: Helsinki
country: Finland
city: Tampere
country: Finland
city: Boulogne Billancourt
country: France
city: Nice
country: France
city: Paris Cedex 13
country: France
city: Paris
country: France
city: Paris
country: France
city: Saint - Etienne Cedex 2
country: France
city: Athens
country: Greece
city: Athens
country: Greece
city: Pecs
country: Hungary
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Chieti
country: Italy
city: Milan
country: Italy
city: Naples
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Rimini
country: Italy
city: Rionero in Vulture
country: Italy
city: Roma
country: Italy
city: Taormina
country: Italy
city: Nieuwegein
country: Netherlands
city: Zwolle
country: Netherlands
city: Bydgoszcz
country: Poland
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Warsawa
country: Poland
city: Bucuresti
country: Romania
city: Timisoara
country: Romania
city: Bratislava
country: Slovakia
city: Jesenice
country: Slovenia
city: Ljubljana
country: Slovenia
city: Badalona
country: Spain
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cataluna
country: Spain
city: Ferrol
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Salamanca
country: Spain
city: Brighton
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Solihull
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Use Central Contact
role: STUDY_CHAIR
References: