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NCT03015532 · ClinicalTrials.gov registry record · Phase 2
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
A Phase 2 study of Postoperative Pain, sponsored by Heron Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 285
- Enrollment target
- 20
- Study locations
NCT03015532: Completed Phase 2 study of Postoperative Pain, sponsored by Heron Therapeutics.
NCT03015532 is a Phase 2 study of Postoperative Pain that has completed, run by Heron Therapeutics. The registered enrollment target is 285 participants, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03015532, a Phase 2 study of Postoperative Pain, has completed, sponsored by Heron Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 285 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.
Primary Outcome
Pain intensity is assessed at rest 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 AUC0-48 is 0-480.
Conditions Studied
Interventions
- DRUG Saline Placebo
- DRUG Ropivacaine
- DRUG HTX-011
- DRUG Bupivicaine HCl
Study Locations (20)
Texas
- - Bellaire
- - Houston
- - Houston
- - Houston
- - Plano
Florida
- - Miami
- - Miami
- - Miami
- - Tamarac
California
- - La Jolla
- - Riverside
- - San Diego
Ohio
- - Columbus
- - Columbus
- - Dayton
Alabama
- - Mobile
- - Sheffield
Arizona
- - Phoenix
- - Phoenix
Nevada
- - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2017-01-13 |
| Est. Completion | 2018-05-16 |
| Phase | Phase 2 |
What the finished NCT03015532 record still lists
NCT03015532 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (24% higher).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 4 interventions - of which Saline Placebo is the first listed.
NCT03015532 names 20 study sites across 7 states, led by Texas, Florida, California.
Frequently Asked Questions
What is clinical trial NCT03015532 about?
NCT03015532 is a clinical study titled "Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia". This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgica...
What is the current status of trial NCT03015532?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 285 participants. The study started on 2017-01-13. Estimated completion is 2018-05-16.
What conditions does trial NCT03015532 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT03015532?
The interventions under investigation include: Saline Placebo (DRUG), Ropivacaine (DRUG), HTX-011 (DRUG), Bupivicaine HCl (DRUG).
Who is sponsoring clinical trial NCT03015532?
This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03015532 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Nevada. 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 NCT03015532's enrollment target sits among peer trials
285 21st of 120 higher than 100 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
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