Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02675907 · ClinicalTrials.gov registry record · Phase 3
Evaluation of N1539 Following Bunionectomy Surgery
A Phase 3 study of Pain, Postoperative, sponsored by Baudax Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 201
- Enrollment target
- 4
- Study locations
NCT02675907: Completed Phase 3 study of Pain, Postoperative, sponsored by Baudax Bio.
NCT02675907 is a Phase 3 study of Pain, Postoperative that has completed, run by Baudax Bio. The registered enrollment target is 201 participants, below the 271-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (26% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02675907, a Phase 3 study of Pain, Postoperative, has completed, sponsored by Baudax Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 201 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
Primary Outcome
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference
Conditions Studied
Interventions
- DRUG Intravenous Placebo
- DRUG N1539
Study Locations (4)
California
- Trovare Clinical Research - Bakersfield
- Lotus Clinical Research - Pasadena
Maryland
- Chesapeake Research Group - Pasadena
Texas
- Endeavor Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT02675907 record still lists
NCT02675907 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 271-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Intravenous Placebo is the first listed.
NCT02675907 reports a single indexed study location in California, Maryland, Texas.
Frequently Asked Questions
What is clinical trial NCT02675907 about?
NCT02675907 is a clinical study titled "Evaluation of N1539 Following Bunionectomy Surgery". The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
What is the current status of trial NCT02675907?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2016-01. Estimated completion is 2016-07.
What conditions does trial NCT02675907 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT02675907?
The interventions under investigation include: Intravenous Placebo (DRUG), N1539 (DRUG).
Who is sponsoring clinical trial NCT02675907?
This trial is sponsored by Baudax Bio, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02675907 being conducted?
This trial has 4 study locations across California, Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain, Postoperative
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 NCT02675907's enrollment target sits among peer trials
201 16th of 113 higher than 98 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative 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
-
Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression
RECRUITING · Phase 3
-
Opioid-Free Orthopaedics
RECRUITING · Phase 3
-
Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
COMPLETED · Phase 3
-
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
COMPLETED · Phase 3
-
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
COMPLETED · Phase 3
-
Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
COMPLETED · Phase 3
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
- NCT04422652 · 201 participants · Phase 2
Combination of Novel Therapies for CKD Comorbid Depression
- NCT05327114 · 201 participants · Phase 2
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- NCT06099769 · 201 participants · Phase 2
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
- NCT06274528 · 201 participants · Phase 2
DORA and LP in Alzheimer's Disease Biomarkers
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia