HTX-011 Administration Study in Planned Caesarean Section Procedure

NCT03955211 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: HTX-011-220
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

postoperative pain; caesarean section; C-section

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Mean area under the curve of the NRS pain scores through 72 hours (AUC0-72).

  72 hours

• Incidence of treatment-emergent adverse events (TEAEs).

  28 Days.

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

A single dose of HTX-011 administered via instillation into the surgical site.

Drug: HTX-011; Device: Luer Lock Applicator

Treatment Group 2

EXPERIMENTAL

A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen.

Drug: HTX-011; Device: Luer Lock Applicator; Drug: Ibuprofen; Drug: Acetaminophen

Interventions

HTX-011 DRUG

300 mg

Also known as: Cohort 1

Treatment Group 1

Luer Lock Applicator DEVICE

Applicator for instillation.

Treatment Group 1; Treatment Group 2

Ibuprofen DRUG

400 mg

Treatment Group 2

Acetaminophen DRUG

975 mg to 1 g

Treatment Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (4)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

KPNA1 protein, human; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 20, 2019
• Study Start: June 24, 2019
• Primary Completion: December 3, 2021
• Study Completion: December 27, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

US (4)