NL-OMON34497
Completed
Phase 4
A multicenter, Single arm, Open label study of The Repeated Administration Of Qutenza For The Treatment Of Peripheral Neuropathic Pain. - STRIDE
Astellas Pharma B.V.0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- pain that is caused by damage to the peripheral nerves
- Sponsor
- Astellas Pharma B.V.
- Enrollment
- 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be included in the clinical trial, subjects must meet all of the 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, non\-irritated, dry 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 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)
Exclusion Criteria
- •Subjects will be excluded from the clinical trial if they meet any of the following 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 any prior chronic substance abuse (including alcoholism) likely to re\-occur during the study period as judged 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.
Outcomes
Primary Outcomes
Not specified
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