Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

NCTNCT02100956Other idIRB00027272

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Cessation of funding period prior to completion, due to slow recruitment during the pandemic

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 8 participants (actual)
Sponsor: Wake Forest University Health Sciences · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: 19 Jun 2014
Primary completion: 10 Oct 2022
Completion: 10 Oct 2022
First posted: 1 Apr 2014 (estimated)
Last update posted: 3 Oct 2023
Conditions: Neuropathic Pain

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142016201820202022

Ph 2
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
NCT02100956
19 Jun 2014 to 10 Oct 2022
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

oxytocin 100 microgramsDrug
Normal Saline (preservative free)Drug

Arms2

Experimental
Oxytocin, then Placebo
The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
Experimental
Placebo, then Oxytocin
The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.

Primary outcomes1

Outcomes the sponsor listed as primary.

Spontaneous Pain From Their Neuropathic Pain Disease
Time frame · 240 minutes post injection
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 240 minutes post injection

Spontaneous Pain From Their Neuropathic Pain Disease

Group	Value (score on a scale)	Spread
Oxytocin Injection	1.67	0.87
Placebo Injection	2.43	0.89

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocin InjectionParticipants who received intrathecal oxytocin injection on either the first or second study day	0 / 6	0 / 6	0 / 6
Placebo InjectionPatients who received normal saline placebo injection on either the first or second study day.	0 / 6	0 / 6	1 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

5 results

Preliminary results from a randomized, controlled, cross-over trial of intrathecal oxytocin for neuropathic pain.

Eisenach et al. 2023Pain medicine (Malden, Mass.)cited by 5

PMID 37084261PMC10472486DOI 10.1093/pm/pnad051PUB-37084261

Rights unknown5 results

Source link See results (5)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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