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Clinical Trials/EUCTR2019-003502-28-DE
EUCTR2019-003502-28-DE
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

Algiax Pharmaceuticals GmbH0 sites96 target enrollmentDecember 6, 2019
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ConditionsPeripheral post-surgical neuropathic painMedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Peripheral post-surgical neuropathic pain
Sponsor
Algiax Pharmaceuticals GmbH
Enrollment
96
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 6, 2019
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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), hernia repair of the abdominal wall (i.e. femoral hernia repairs, inguinal hernia repairs, umbilical hernia repair or incisional hernia repair), abdominal surgery (i.e. cholecystectomy, appendectomy), varicose vein surgery or gynecologic surgery (i.e. hysterectomy, C\-section)
  • •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 e.g., the pain is at least partially due to pain in deeper structures such as internal organs, joints, muscles or bones.
  • •3\. 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
  • •4\. Subjects using adjuvant chemotherapy or radiotherapy; adjuvant therapies must have been finished at least 4 weeks prior to the run\-in period (Day \-14\)
  • •5\. Creatinine clearance \<60 mL/min using the Cockcroft\-Gault formula
  • •6\. White blood cell count \<2500/mm³; neutrophil count \<1500/mm³; platelet count \<100 x 10³/mm³
  • •7\. Heart rate \<50 or \>100 beats per minute; systolic blood pressure \<100 or \>140 mmHg; diastolic blood pressure \<50 or \>90 mmHg
  • •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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