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HTX-011 Administration Study in Planned Caesarean Section Procedure

NCT03955211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-03-14

No results posted yet for this 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.

Conditions

  • Analgesia

Interventions

DRUG

HTX-011

300 mg

DRUG

HTX-011

400 mg

DEVICE

Luer Lock Applicator

Applicator for instillation.

DRUG

Ibuprofen

400 mg

DRUG

Acetaminophen

975 mg to 1 g

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2021-12-03
Completion
2021-12-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03955211 on ClinicalTrials.gov