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HTX-011 Administration Study in Planned Caesarean Section Procedure

OverviewStructured DataIssuesContributors

Contents

clinicaltrials.gov/study/NCT03955211
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT039552110
Health Conditions in Trial
‌
Analgesia
0
Trial Recruitment Size
250
Trial Sponsor
Heron Therapeutics
Heron Therapeutics
0
Clinical Trial Start Date
June 24, 2019
0
Primary Completion Date
December 3, 2021
0
Study Completion Date
December 27, 2021
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Drug0
Intervention Name
Acetaminophen0
HTX-0110
Ibuprofen0
Luer Lock Applicator0
Interventional Trial Phase
Phase 20
Participating Facility
‌
SHARP MARY BIRCH HOSPITAL FOR WOMEN AND NEWBORNS
0
‌
Helen Keller Hospital
0
Official Name
A Phase 2 Open-Label Study of the Pharmacokinetics (PK) and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section0
Last Updated
March 14, 2022
0
Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study summary

This is a Phase 2, open-label study to evaluate the PK and safety of HTX-011 in women undergoing a planned C-section.

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