Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Efficacy of Spinal Oxytocin in Healthy Volunteers

NCTNCT01996605Other idIRB00025901

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: 20 participants (actual)
Sponsor: Wake Forest University Health Sciences · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: 2 Jan 2014
Primary completion: 10 Oct 2022
Completion: 10 Oct 2022
First posted: 27 Nov 2013 (estimated)
Last update posted: 14 Sept 2023
Conditions: Healthy Volunteer Study

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 Spinal Oxytocin in Healthy Volunteers
NCT01996605
2 Jan 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 this study is to determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Interventions

Oxytocin 15 mcgDrug
Oxytocin 150 mcgDrug
PlaceboDrug

Arms3

Experimental
Oxytocin 15 mcg
Oxytocin 15 mcg injected spinally
Experimental
Oxytocin 150 mcg
Oxytocin 150 mcg injected spinally
Active comparator
Placebo
Preservative free normal saline injected spinally

Primary outcomes1

Outcomes the sponsor listed as primary.

Hyperalgesia
Time frame · 105 minutes after study drug injection
Registry description
The area of hyperalgesia after the first skin heating following topical capsaicin.

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· 105 minutes after study drug injection

Hyperalgesia

Group	Value (square centimeters)	Spread
Oxytocin 15 mcg	103	55
Oxytocin 150 mcg	102	76
Placebo	75	33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocin 15 mcgOxytocin 15 mcg injected spinally Oxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally	0 / 8	0 / 8	0 / 8
Oxytocin 150 mcgOxytocin 150 mcg injected spinally Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally	0 / 5	0 / 5	0 / 5
PlaceboPreservative free normal saline injected spinally Placebo: placebo will be administered spinally	0 / 7	0 / 7	0 / 7

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 59 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * healthy * weight \< 240 pounds * American Society of Anesthesiology Category 1 or 2 Exclusion Criteria: * allergy to oxytocin or lidocaine * allergy to chilli peppers * Females: active gynecological disease such as uterine fibroids or ongoing bleeding * Pregnancy or currently breastfeeding * Females that have delivered a baby within 2 years of study * Taking prescription medications (exception: oral birth control medication)

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