Oxytocin for Pain Assessment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Baylor College of Medicine, Houston, TX
Pain Assessment+3 More
Oxytocin - Drug
Eligibility
18 - 65
Female
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Study Summary

The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome.

Eligible Conditions

  • Pain Assessment
  • Ehlers-Danlos Syndrome

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: For each arm we will compare pain levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. This difference will be compared between the two treatment arms.

Day 6
Changes in anxiety assessment
Day 3
Change in activity level
Day 3
Change in heart rate patterns
Day 6
Changes in depression assessment
Day 6
Change in participant's pain levels assessed by numerical rating
Change in participant's pain levels by evaluating pain experience
Change in participant's subjective reported chronic pain

Trial Safety

Trial Design

2 Treatment Groups

Oxytocin
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

20 Total Participants · 2 Treatment Groups

Primary Treatment: Oxytocin · Has Placebo Group · Phase 1 & 2

Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Oxytocin
Drug
ActiveComparator Group · 1 Intervention: Oxytocin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: for each arm we will compare pain levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. this difference will be compared between the two treatment arms.
Closest Location: Baylor College of Medicine · Houston, TX
Photo of baylor college of medicine 1Photo of baylor college of medicine 2Photo of baylor college of medicine 3
2003First Recorded Clinical Trial
1 TrialsResearching Pain Assessment
802 CompletedClinical Trials

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
910 Previous Clinical Trials
5,981,746 Total Patients Enrolled
Brendan Lee, MD, PhDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
18 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.