Clinical trial

Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Name
IRB00027272
Description
The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.
Trial arms
Trial start
2014-06-19
Estimated PCD
2022-10-10
Trial end
2022-10-10
Status
Terminated
Phase
Early phase I
Treatment
oxytocin 100 micrograms
oxytocin 100 micrograms administered intrathecally (IT)
Arms:
Oxytocin, then Placebo, Placebo, then Oxytocin
Normal Saline (preservative free)
Normal Saline (preservative free) administered intrathecally (IT)
Arms:
Oxytocin, then Placebo, Placebo, then Oxytocin
Size
8
Primary endpoint
Spontaneous Pain From Their Neuropathic Pain Disease
240 minutes post injection
Eligibility criteria
Inclusion Criteria: * Weight \< or equal to 240 pounds * Neuropathic pain for \> 6 months: with primary pain area below the umbilicus Exclusion Criteria: * Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine * Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data * Pregnancy * spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for \> 3 months at a current dose of \> 100 milligram (mg) morphine per day or equivalent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}
Updated at
2023-10-03

1 organization

2 products

1 indication

Product
Oxytocin