A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pai

Conditions: Peripheral Neuropathic Pain in Postherpetic Neuralgia (PHN), Painful HIV-Associated Neuropathy (HIV-AN), Peripheral Neuropathic Injury (PNI), Idiopathic Small Nerve Neuropathy (ISNN) or other Peripheral Neuropathic Pain (PNP).
MedDRA version: 14.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2009-016457-18-NL

Lead Sponsor: Astellas Pharma Europe Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

Common Inclusion Criteria:
1. Male or female between 18 and 90 years of age, inclusive
2. Be in good health as determined by the investigator
3. Average pain score >=4 during screening period (using the average reported pain from the Brief Pain Inventory [BPI])
4. Intact, unbroken skin over the painful area(s) to be treated
5. 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
6. Be willing and able to comply with protocol requirements for the duration of study participation
7. Subject has given written informed consent

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 peripheral neuropathic pain 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)
Confirmation of HIV-AN existing for a minimum of 3 months, as assessed using the Brief Peripheral Neuropathy Screen (BPNS)
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 and electrodiagnostic criteria:
Neuropathy exclusively or predominantly affecting A-d (small myelinated) and nociceptive C (unmyelinated) nerve fibres
Loss of pinprick and temperature sensation in feet
Or
Other Peripheral Neuropathic Pain (PNP)
Adequately characterized peripheral neuropathic pain based on clinical history and examination existing at the time of screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Any prior receipt of QUTENZA open label or blinded study patches
2.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.
3.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 oxicodone or other analgesic, as judged by the investigator
4.Active substance abuse or history of chronic substance abuse within 1 year prior to enrolment or prior chronic substance abuse (including alcoholism) judged likely to re-occur during the study period by the investigator
5.Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anaesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application visit
6.Current use of any investigational agent (excluding antiretrovirals in Phase 3 evaluation to treat HIV infection)
7.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
8.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
9.Past or current history of Type I or Type II diabetes mellitus
10.Current psychotic disorders
11.Clinically significant abnormal ECG at screening
12.Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products),any QUTENZA excipients, local anaesthetics, oxycodone, hydrocodone, or adhesives
13.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
14.Significant pain of an aetiology other than painful HIV-AN, PHN, PNI, ISNN or other adequately characterized peripheral neuropathic pain for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis
15.Posttraumatic neuropathic pain due to Complex Regional Pain Syndrome (CRPS, Type I)
16.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)
17.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
18. Planned elective surgery during the trial
19.Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
20.Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials