HTX-011 Administration Study in Planned Caesarean Section Procedure
Phase 2
Completed
- Conditions
- Analgesia
- Interventions
- Registration Number
- NCT03955211
- Lead Sponsor
- Heron Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group 2 Acetaminophen A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen. Treatment Group 1 HTX-011 A single dose of HTX-011 administered via instillation into the surgical site. Treatment Group 1 Luer Lock Applicator A single dose of HTX-011 administered via instillation into the surgical site. Treatment Group 2 HTX-011 A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen. Treatment Group 2 Luer Lock Applicator A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen. Treatment Group 2 Ibuprofen A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen.
- Primary Outcome Measures
Name Time Method 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 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 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
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (4)
Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States
UPMC Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Helen Keller Hospital
🇺🇸Sheffield, Alabama, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States