Oxytocin Pharmacokinetics After Intramuscular Injection

NCT04427540 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB00065842
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Study participants will have an intravenous catheter (IV) inserted in the forearm. A single intramuscular (IM) injection of oxytocin (Pitocin®), 17 micrograms will be administered and blood samples will be taken several times over the next 120 minutes. The amount of oxytocin will be measured in the blood samples. The main purpose of this study is to sample the blood, before and after the administration of oxytocin and calculate the pharmacokinetics (amount of oxytocin in the blood over time) of oxytocin.

Conditions

Osteoarthritis, Knee

Keywords

advanced knee arthritis

Outcome Measures

Primary Outcomes (1)

• Oxytocin concentration in serum

  Amount of Oxytocin in serum measured in picograms/millilitres (pg/ml) after IM Oxytocin administered

  1 minute post administration to 120 minutes post administration

Study Arms (1)

Oxytocin

EXPERIMENTAL

Single IM injection Oxytocin 17 micrograms

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin 10 micrograms IM

Also known as: Pitocin

Oxytocin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.
• \. Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3.
• \. Normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
• \. Female subjects of child-bearing potential and those \< 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
• \. diagnosis of advanced knee arthritis

You may not qualify if:

• \. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
• \. 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
• \. Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
• \. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single IM injection of Oxytocin 17 micrograms

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share