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

Algiax Pharmaceuticals GmbH0 sites94 target enrollmentDecember 10, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Algiax Pharmaceuticals GmbH
Enrollment: 94
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 10, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Algiax Pharmaceuticals GmbH

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 and able to discontinue and washout prohibited substances including
•pain medications (e.g. antidepressants, anticonvulsants/antiepileptics, selective serotonin and dual reuptake inhibitors, opioids, 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
•Note: Subjects using prohibited substances for other indications than neuropathic pain, e.g. antiepileptics for the treatment of epilepsy, may not be included in the study , because a discontinuation of such medication is not medically justifiable.
•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

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 4 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 or radiotherapy; adjuvant therapies must have been finished at least weeks prior to the run\-in period (Day \- 14\)
•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\. Heart rate \<50 or \>100 beats per minute; systolic blood pressure \<100 or \>140 mmHg; diastolic blood pressure \<50 or \>90 mmHg
•9\. A history of multiple drug allergies
•10\. History or presence of alcohol or drug abuse