Trials / Completed
CompletedNCT03955211
HTX-011 Administration Study in Planned Caesarean Section Procedure
A Phase 2 Open-Label Study of the Pharmacokinetics (PK) and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HTX-011 | 300 mg |
| DRUG | HTX-011 | 400 mg |
| DEVICE | Luer Lock Applicator | Applicator for instillation. |
| DRUG | Ibuprofen | 400 mg |
| DRUG | Acetaminophen | 975 mg to 1 g |
Timeline
- Start date
- 2019-06-24
- Primary completion
- 2021-12-03
- Completion
- 2021-12-27
- First posted
- 2019-05-20
- Last updated
- 2022-03-14
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03955211. Inclusion in this directory is not an endorsement.