HTX-011 Administration Study in Planned Caesarean Section Procedure

March 11, 2022 updated by: Heron Therapeutics

A Phase 2 Open-Label Study of the Pharmacokinetics (PK) and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Helen Keller Hospital
    • California
      • San Diego, California, United States, 92123
        • Sharp Mary Birch Hospital for Women and Newborns
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Magee-Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Is expected, at the time of Screening visit, to deliver a single neonate.
  • Is scheduled to undergo a planned C-section surgery with a low transverse skin incision (eg, Pfannenstiel).
  • Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
  • Agrees to practice abstinence or use double-barrier contraception in the event of sexual activity and commits to the use of an acceptable form of birth control for 30 days after HTX-011 administration.
  • Agrees to refrain from the use of breast milk from this pregnancy in any manner.

Exclusion Criteria:

  • Has planned to breastfeed her neonate at any time during the 28-day period after HTX-011 administration.
  • Has had a prior full-term pregnancy with unsuccessful breast milk expression.
  • Has a planned concurrent surgical procedure.
  • Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
  • Has been administered bupivacaine within 5 days prior to the scheduled surgery.
  • Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
  • Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
  • Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.
  • Has taken any NSAIDs within least 10 days prior to the scheduled surgery.
  • Has current significant placental abnormality/complications including, but not limited to, placenta previa or placenta accreta.
  • Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
  • Has uncontrolled anxiety, psychiatric, or neurological disorder.
  • Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
  • Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
  • Previously participated in an HTX-011 study.
  • Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
  • Weight is <50 kg at the time of Screening visit.
  • In the Investigator's judgment, subject is likely to have been morbidly obese prior to her pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group 1
A single dose of HTX-011 administered via instillation into the surgical site.
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
300 mg
Other Names:
  • Cohort 1
Drug: HTX-011
400 mg
Other Names:
  • Cohort 2
Experimental: Treatment Group 2
A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen.
Drug: Ibuprofen
400 mg
Device: Luer Lock Applicator
Applicator for instillation.
Drug: HTX-011
300 mg
Other Names:
  • Cohort 1
Drug: HTX-011
400 mg
Other Names:
  • Cohort 2
Drug: Acetaminophen
975 mg to 1 g

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum plasma concentration (Cmax) of bupivacaine, meloxicam, dimethyl sulfoxide (DMSO) and HTX-011 polymer
Time Frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Time of maximum plasma concentration (Tmax) of bupivacaine, meloxicam, DMSO and HTX-011 polymer
Time Frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Half life (t1/2) in plasma of bupivacaine, meloxicam, DMSO and HTX-011 polymer
Time Frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Half life (t1/2) in milk of bupivacaine, meloxicam, DMSO and HTX-011 polymer
Time Frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Amount of analyte excreted in breast milk over time (Ae)
Time Frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Fraction of dose excreted in breast milk over time (Fe)
Time Frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean area under the curve of the NRS pain scores through 72 hours (AUC0-72).
Time Frame: 72 hours
72 hours
Incidence of treatment-emergent adverse events (TEAEs).
Time Frame: 28 Days.
28 Days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heron Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HTX-011-220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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