NCT01996605|TerminatedPhase 2ResultsDMCFDA Drug
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Cessation of funding period prior to completion, due to slow recruitment during the pandemic
Efficacy of Intrathecal Oxytocin in Human Volunteers
Sponsor study identifier
interventional
20
1 country
1
Study Start
January 2, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 10, 2022
Actual (reported)Study Completion
October 10, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 10, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 21, 2013
Actual (reported)November 27, 2013
Actual (reported)January 2, 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 10, 2022
Actual (reported)October 10, 2022
Actual (reported)September 14, 2023
Actual (reported)Hyperalgesia
The area of hyperalgesia after the first skin heating following topical capsaicin.
105 minutes after study drug injection
Oxytocin 15 mcg injected spinally
Oxytocin 150 mcg injected spinally
Preservative free normal saline injected spinally
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
The study was powered for a sample size of 40 and was terminated early with a sample size of 20 due to slow recruitment and cessation of financial support.
James C Eisenach, MD
Wake Forest University Health Sciences
20 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2013
First Posted
Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin
Apply the PD Model of Peripheral Oxytocin Action to a Multimodal Stimulus
placebo will be administered spinally
Contact the study team to confirm eligibility.
November 27, 2013
Study Start
January 2, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 10, 2022
Actual (reported)Study Completion
October 10, 2022
Actual (reported)Last Updated
September 14, 2023
Results First Posted
September 14, 2023
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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