Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03718039 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Bunionectomy HTX-011 Administration Study
A Phase 2 study of Postoperative Pain, sponsored by Heron Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT03718039: Completed Phase 2 study of Postoperative Pain, sponsored by Heron Therapeutics.
NCT03718039 is a Phase 2 study of Postoperative Pain that has completed, run by Heron Therapeutics. The registered enrollment target is 78 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03718039, a Phase 2 study of Postoperative Pain, has completed, sponsored by Heron Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.
Primary Outcome
Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).
Conditions Studied
Interventions
- DRUG HTX-011
- DEVICE Luer Lock applicator
- DEVICE Vial access device
- DRUG aprepitant
Study Locations (1)
Texas
- Endeavor Clinical Trials, LLC - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2019-03-11 |
| Phase | Phase 2 |
What the finished NCT03718039 record still lists
NCT03718039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 4 interventions - of which HTX-011 is the first listed.
NCT03718039 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03718039 about?
NCT03718039 is a clinical study titled "Phase 2 Bunionectomy HTX-011 Administration Study". This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral si...
What is the current status of trial NCT03718039?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2018-10-24. Estimated completion is 2019-03-11.
What conditions does trial NCT03718039 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT03718039?
The interventions under investigation include: HTX-011 (DRUG), Luer Lock applicator (DEVICE), Vial access device (DEVICE), aprepitant (DRUG).
Who is sponsoring clinical trial NCT03718039?
This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03718039 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03718039's enrollment target sits among peer trials
78 75th of 120 higher than 46 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
RECRUITING · Phase 2
-
Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
RECRUITING · Phase 2
-
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
RECRUITING · Phase 2
-
Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy
COMPLETED · Phase 2
-
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
COMPLETED · Phase 2
-
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02397668 · 78 participants · NA
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
- NCT03321656 · 78 participants · Phase 2
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
- NCT03687814 · 78 participants · NA
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
- NCT04018872 · 78 participants · Phase 2
Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI