EUCTR2019-003502-28-ES
Active, not recruiting
Phase 1
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AP-325 in Subjects with Peripheral Post-surgical Neuropathic Pain
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Peripheral post-surgical neuropathic pain
- Sponsor
- Algiax Pharmaceuticals GmbH
- Enrollment
- 94
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects must be at least 18 years and not older than 80 years
- •2\. Subjects with a diagnosis of chronic post\-surgical neuropathic pain after breast surgery (breast cancer interventions), chest surgery (i.e. thoracotomy, video assisted thoracoscopy and sternotomy) or groin hernia repair (i.e. femoral hernia repairs and inguinal hernia repairs)
- •3\. The chronic post\-surgical pain developed or increased in intensity after the surgical procedure and persisted beyond the healing process, i.e. at least 3 months after the initiating event, as defined according to the international association for the study of pain (IASP) classification of chronic pain for ICD\-11 (Schug et al., 2019\)
- •4\. Subjects must have ‘probable’ or ‘definite’ neuropathic pain as assessed by the revised IASP special interest group on neuropathic pain (NeuPSIG) grading system (Finnerup et al., 2016\)
- •5\. Subjects must be willing to discontinue and washout prohibited substances including
- •pain medications (e.g. antidepressants, anticonvulsants/antiepileptics, selective serotonin and dual reuptake inhibitors, long\-acting benzodiazepines, muscle relaxants, and topical analgesics), except the rescue medication, and
- •substances known to be inhibitors or inducers of CYP2C9 and inhibitors of CYP3A4
- •for specific washout periods of at least 5 times the drug half\-life
- •6\. Permitted concomitant medications must have been stable for at least 4 weeks prior to Day \-14 and any non\-pharmacological therapies (e.g. physiotherapy, acupuncture and transcutaneous electrical neural stimulation) must have been initiated at least 3 weeks prior to Screening
- •7\. Female subjects must not be pregnant or breastfeeding and be
Exclusion Criteria
- •1\. Subjects with neuropathic pain not a result of a surgical procedure as defined in inclusion criterion 2
- •2\. Subjects with any other coexisting pain that cannot be discriminated from post\-surgical neuropathic pain, in the opinion of the subject or clinician
- •3\. Subjects diagnosed with chronic post\-surgical neuropathic pain with a disease duration exceeding 3 years
- •4\. Inability to participate in the study, in the opinion of the investigator, because of, for example, severe brain damage, language barrier, dementia, or other clinically significant or unstable conditions
- •5\. Subjects using adjuvant chemotherapy
- •6\. Creatinine clearance \<60 mL/min using the Cockcroft\-Gault formula
- •7\. White blood cell count \<2500/mm³; neutrophil count \<1500/mm³; platelet count \<100 x 10³/mm³
- •8\. A history of multiple drug allergies
- •9\. History or presence of alcohol or drug abuse
- •10\. Subjects using strong opioids (e.g. a Morphine Equivalent Dose \[MED] \>80 mg/day)
Outcomes
Primary Outcomes
Not specified
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