HTX-011 Administration Study in Planned Caesarean Section Procedure

NCT ID: NCT03955211

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2021-12-27

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group 1

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

Group Type: EXPERIMENTAL

HTX-011

Intervention Type: DRUG

300 mg

Luer Lock Applicator

Intervention Type: DEVICE

Applicator for instillation.

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.

Group Type: EXPERIMENTAL

HTX-011

Intervention Type: DRUG

400 mg

Luer Lock Applicator

Intervention Type: DEVICE

Applicator for instillation.

Ibuprofen

Intervention Type: DRUG

400 mg

Acetaminophen

Intervention Type: DRUG

975 mg to 1 g

Interventions

HTX-011

300 mg

Intervention Type: DRUG

HTX-011

400 mg

Intervention Type: DRUG

Luer Lock Applicator

Applicator for instillation.

Intervention Type: DEVICE

Ibuprofen

400 mg

Intervention Type: DRUG

Acetaminophen

975 mg to 1 g

Intervention Type: DRUG

Other Intervention Names

Cohort 1; Cohort 2

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Heron Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Helen Keller Hospital

Sheffield, Alabama, United States

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

Duke University Medical Center

Durham, North Carolina, United States

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

HTX-011-220

Identifier Type: -

Identifier Source: org_study_id