Have you or your loved ones been diagnosed with neuropathic pain?

You may be eligible to participate in a neuropathic pain clinical trial.

Have you or your loved ones been diagnosed with neuropathic pain? You may be eligible to participate in a neuropathic pain clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Neuropathic Pain Clinical Trial in Winston-Salem NC

NCT02100956 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with neuropathic pain?

You may be eligible to participate in a neuropathic pain clinical trial.

Have you or your loved ones been diagnosed with neuropathic pain? You may be eligible to participate in a neuropathic pain clinical trial.

Terminated

Male & Female

18 - 70

Years old

This study has recruited 7 Participants

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.

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Details for the study

Brief Title

Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Official Title

Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Brief Summary

The purpose of the study is to determine the effect of oxytocin given into the spinal fluid <br /> on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic <br /> neuropathic pain.

Detailed Description

Rationale: The investigators anticipate that oxytocin will be effective after spinal
injection in humans to acutely relieve chronic neuropathic pain.

Objectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of
hyperalgesia and allodynia in patients with chronic neuropathic pain.

Interventions: A computer generated randomization will be used to determine the group for
each subject. Subjects will be randomized to receive an intrathecal injection of saline
(placebo) or oxytocin.

Treatments and/or Procedures

Normal saline preservative free

Normal Saline (preservative free) administered intrathecally (IT)

Oxytocin 100 micrograms

oxytocin 100 micrograms administered intrathecally (IT)

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Spontaneous pain from their neuropathic pain disease

Pain will be measured by visual analog scale, a 10 cm line with "no pain" on one end and "pain as worse as can be" on the other. The subject places a mark on the line and the score is determined by the distance in cm from the "no pain" end.

60 minutes post injection

Study 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.