HTX-011 Administration Study in Planned Caesarean Section Procedure

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955211
• Other study ID #: HTX-011-220
• Status: Completed
• Phase: Phase 2
• Start date: June 24, 2019
• Est. completion date: December 27, 2021

Study information

• Verified date: March 2022
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 27, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• HTX-011
300 mg
• HTX-011
400 mg

Device:
• Luer Lock Applicator
Applicator for instillation.

Drug:
• Ibuprofen
400 mg
• Acetaminophen
975 mg to 1 g

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	UPMC Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California
United States	Helen Keller Hospital	Sheffield	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of bupivacaine, meloxicam, dimethyl sulfoxide (DMSO) and HTX-011 polymer		Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Primary	Time of maximum plasma concentration (Tmax) of bupivacaine, meloxicam, DMSO and HTX-011 polymer		Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Primary	Half life (t1/2) in plasma of bupivacaine, meloxicam, DMSO and HTX-011 polymer		Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Primary	Half life (t1/2) in milk of bupivacaine, meloxicam, DMSO and HTX-011 polymer		Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Primary	Amount of analyte excreted in breast milk over time (Ae)		Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Primary	Fraction of dose excreted in breast milk over time (Fe)		Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Secondary	Mean area under the curve of the NRS pain scores through 72 hours (AUC0-72).		72 hours
Secondary	Incidence of treatment-emergent adverse events (TEAEs).		28 Days.