An interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial evaluating the efficacy and safety of Qutenza® in subjects with post-surgical neuropathic pain - AV001 (ICON 0389/0067)

Averitas Pharma, Inc.0 个研究点目标入组 49 人开始时间: 待定最近更新: 2024年4月15日

试验速览

阶段: 3 期
状态: 招募中
发起方: Averitas Pharma, Inc.
入组人数: 49

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 64（—）

入选标准

•1. The subject has given written informed consent to participate.
•2. Female or male subjects aged 18 years or older.
•3. For women of childbearing potential: negative pregnancy tests at Screening
•Visit (Visit 1), the Randomization Visit (Visit 2), and prior to each
•reapplication of the IMP, and must have agreed to practice medically acceptable
•methods of birth control.
•Confirmation of diagnosis of chronic moderate to severe PSNP (see also Protocol
•4. Documented diagnosis of PSNP by the following criteria:
•a. A history of post-surgical pain with a duration of at least 6 months to
•maximally 60 months that is plausibly related to the surgical intervention as
•documented on a body map.
•b. DN4i of at least 3 out of 7 points at Visit 1.
•c. The pain must extend beyond the scar area to neuroanatomically adjacent skin
•areas and be related to the site of the surgery.
•5. Documented diagnosis of probable or definite PSNP according to the following
•a. The pain must be associated with sensory signs in the same neuroanatomically
•plausible distribution. The area of sensory changes may extend beyond, be
•within, or overlap with the area of pain (criterion for probable neuropathic
•b. In addition to 5a : Direct surgical evidence (e.g., surgeon*s clear
•verification of an intraoperative nerve lesion) (criterion for definite
•neuropathic pain).
•6. The subject has moderate to severe pain with a baseline value for 24-hr
•average pain intensity of at least 4 points on the NPRS. The baseline value is
•calculated as the average of the 24-hr average pain intensity ratings of the
•Baseline Phase (Day -7 to Day -1). At least 5 (out of the last 7 days) pain
•ratings should be available during the Baseline Phase. If less than 5 pain
•ratings are available in the last 7 days, the subject may be rescheduled for
•Visit 2 (1 time only) after having received appropriate re-training in the use
•of the e-diary to ensure compliance.
•Suitability for treatment with IMP
•7. The size of the affected painful intact skin area is not larger than the
•size of 4 standard Qutenza topical systems (1120 cm2).
•8. The skin in the area where the IMP will be applied, and that may also
•contain the scar tissue, is intact, dry, and non-irritated (i.e., there are no
•signs and symptoms of skin disease, skin irritation, inflammation or injury,
•such as active herpes zoster lesions, atopic dermatitis, ulceration, wounds).
•This is reflected by a dermal assessment score of 0 = no evidence of
•irritation or 1 = minimal erythema, barely perceptible.
•Eligibility with regard to protocol adherence, to allowed pre-treatments and
•concomitant treatments
•9. The subject is willing to adhere to the restricted use of concomitant
•treatments (see concomitant treatments in Section 1.4.2).
•10. The subject experiencing pain is:
•a. currently not receiving treatment for PSNP or
•b. receives a stable systemic treatment for PSNP that started more than 30 days
•prior to the Randomization Visit (Visit 2).

排除标准

•General or previous treatments 1. The subject received Qutenza before the
•Randomization Visit (Visit 2) or received a medical device in another clinical
•trial within 7 days before the Randomization Visit (Visit 2), or a. Any former
•use of topical capsaicin in the area of the PSNP before Visit 2, except for the
•use of a low-dose (<1%) capsaicin product - but not within 7 days before Visit
•2. b. The subject participated previously in this clinical trial or
•participated in another clinical trial for the treatment of PSNP completing
•less than 3 months ago. 2. A score of 0 out of 5 in all 3 categories of the
•neurological/sensory examinations, i.e., for warm sensation, pinprick and cold
•sensation at the Screening Visit (Visit 1). Confounding factors 3. The subject
•reported a 24-hr average pain intensity score of 10 on the NPRS for at least 4
•days during the Baseline Phase. 4. Any painful procedure planned during the
•course of the trial that may, in the opinion of the investigator, affect the
•efficacy or safety assessments. 5. Subjects with PSNP related to a
•surgery/condition with a high potential for confounding symptoms, e.g., the
•pain is at least partially due to pain in deeper structures such as muscles or
•bones (including referred pain from deeper structures) as listed in examples in
•Protocol Table 2. 6. Other painful conditions in the body area that is affected
•by PSNP and may affect efficacy or safety assessments and cannot be
•discriminated from the target pain by the subject, including infectious,
•non-infectious, inflammatory or neuropathic conditions which could also be
•complications related to the previous surgical procedure. Contraindications to
•IMP 7. Neuropathic pain areas located only on the face, above the hairline of
•the scalp, and/or in proximity to mucous membranes. 8. Hypersensitivity to
•capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products),
•or to any excipients of the IMP or to excipients of the cleansing gel in use
•and their components, or to topical anesthetics in use and their components.
•Medical history/concurrent condition(s)/other factors 9. Pending litigation due
•to chronic pain or disability. 10. The subject has a history of alcohol or drug
•abuse or is actively abusing drugs (including alcohol, medication) during the 1
•year prior to the Screening Visit (Visit 1) as judged by the investigator. 11.
•Evidence or history of severe psychiatric illness/disorder during the 3 years
•prior to the Screening Visit (Visit 1) that, in the investigator*s opinion, may
•affect efficacy or safety assessments or may compromise the subject*s safety
•during trial participation, e.g., major depression, major anxiety disorder,
•psychosis, severe personality disorders. 12. Evidence of cognitive impairment
•including dementia that may interfere with the subject*s ability to complete
•pain assessments requiring recall of the average pain level in the past 24 hrs.
•13. Surgical intervention in the last 3 months preceding the Screening Visit
•(Visit 1) if it is affecting the efficacy or safety assessments, or any
•scheduled or planned surgery during the trial, with the exception of the
•Extension Phase if the planned surgery is not expected to affect the efficacy
•or safety assessments. 14. Patients with current clinically significant
•disease(s) or condition(s

研究者

发起方

Averitas Pharma, Inc.

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