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NCT03011333 · ClinicalTrials.gov registry record · Phase 2
Phase 2B Upper Extremity Nerve Block Study
A Phase 2 study, sponsored by Heron Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 243
- Enrollment target
NCT03011333: Completed Phase 2 study, sponsored by Heron Therapeutics.
NCT03011333 is a Phase 2 study that has completed, run by Heron Therapeutics. The registered enrollment target is 243 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03011333, a Phase 2 study, has completed, sponsored by Heron Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 243 participants
- Enrollment target
Study Summary
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.
Primary Outcome
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.
Interventions
- DRUG Saline Placebo
- DRUG HTX-011
- DRUG Bupivacaine HCl without epinephrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2017-01-14 |
| Est. Completion | 2018-03-19 |
| Phase | Phase 2 |
What the finished NCT03011333 record still lists
NCT03011333 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 3 interventions - of which Saline Placebo is the first listed.
NCT03011333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03011333 about?
NCT03011333 is a clinical study titled "Phase 2B Upper Extremity Nerve Block Study". This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectora...
What is the current status of trial NCT03011333?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 243 participants. The study started on 2017-01-14. Estimated completion is 2018-03-19.
What interventions are being tested in trial NCT03011333?
The interventions under investigation include: Saline Placebo (DRUG), HTX-011 (DRUG), Bupivacaine HCl without epinephrine (DRUG).
Who is sponsoring clinical trial NCT03011333?
This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03011333's enrollment target sits among peer trials
243 236th of 2000 higher than 1,764 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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