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NCT02169336 · ClinicalTrials.gov registry record · Phase 2
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
A Phase 2 study, sponsored by Baudax Bio.
- Terminated
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT02169336: Clinical Trial Phase 2 study, sponsored by Baudax Bio.
NCT02169336 is a Phase 2 study that was terminated before completion, run by Baudax Bio. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02169336, a Phase 2 study, was terminated before completion, sponsored by Baudax Bio.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.
Primary Outcome
Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations we
Interventions
- OTHER Intranasal Placebo
- DRUG Intranasal Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2014-06 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
Why NCT02169336 stopped before completion
NCT02169336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Intranasal Placebo is the first listed.
NCT02169336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02169336 about?
NCT02169336 is a clinical study titled "Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy". The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.
What is the current status of trial NCT02169336?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2014-06. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02169336?
The interventions under investigation include: Intranasal Placebo (OTHER), Intranasal Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT02169336?
This trial is sponsored by Baudax Bio, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02169336's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 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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