Back to resultsEfficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Primary Purpose
Neuropathic Pain
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxytocin 100 micrograms
Normal Saline (preservative free)
Sponsored by
About this trial
This is an interventional basic science trial for Neuropathic Pain focused on measuring chronic pain, neuropathic pain
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.
Sites / Locations
- Wake Forest School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oxytocin, then Placebo
Placebo, then Oxytocin
Arm Description
The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.
Outcomes
Primary Outcome Measures
Spontaneous Pain From Their Neuropathic Pain Disease
Pain will be measured by visual analog scale, a 10 cm line with 0/"no pain" on the left end and 10/"pain as worse as can be" on the right end. The subject places a mark on the line and the score is determined by the distance in cm from the "no pain" end.
Secondary Outcome Measures
Full Information
NCT ID
NCT02100956
First Posted
March 27, 2014
Last Updated
September 8, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02100956
Brief Title
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Official Title
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Cessation of funding period prior to completion, due to slow recruitment during the pandemic
Study Start Date
June 19, 2014 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
chronic pain, neuropathic pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin, then Placebo
Arm Type
Experimental
Arm Description
The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
Arm Title
Placebo, then Oxytocin
Arm Type
Experimental
Arm Description
The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.
Intervention Type
Drug
Intervention Name(s)
oxytocin 100 micrograms
Intervention Description
oxytocin 100 micrograms administered intrathecally (IT)
Intervention Type
Drug
Intervention Name(s)
Normal Saline (preservative free)
Intervention Description
Normal Saline (preservative free) administered intrathecally (IT)
Primary Outcome Measure Information:
Title
Spontaneous Pain From Their Neuropathic Pain Disease
Description
Pain will be measured by visual analog scale, a 10 cm line with 0/"no pain" on the left end and 10/"pain as worse as can be" on the right end. The subject places a mark on the line and the score is determined by the distance in cm from the "no pain" end.
Time Frame
240 minutes post injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C. Eisenach, M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
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