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NCT02284243 · ClinicalTrials.gov registry record · Phase 2
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery
A Phase 2 study of Pain, Postoperative, sponsored by Baudax Bio.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
- 3
- Study locations
NCT02284243: Completed Phase 2 study of Pain, Postoperative, sponsored by Baudax Bio.
NCT02284243 is a Phase 2 study of Pain, Postoperative that has completed, run by Baudax Bio. The registered enrollment target is 168 participants, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (38% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02284243, a Phase 2 study of Pain, Postoperative, has completed, sponsored by Baudax Bio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, 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 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, 2, 4, and 6 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 were calculated at each time point and a time weighted summed pain intensity diff
Conditions Studied
Interventions
- DRUG Intranasal Dexmedetomidine
- DRUG Intranasal Placebo
Study Locations (3)
California
- Trovare Clinical Research, Inc. - Bakersfield
- Lotus Clinical Research, LLC - Pasadena
Texas
- Endeavor Clinical Trials, P.A. - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT02284243 record still lists
NCT02284243 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Intranasal Dexmedetomidine is the first listed.
NCT02284243 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT02284243 about?
NCT02284243 is a clinical study titled "Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery". The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, 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 NCT02284243?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2014-10. Estimated completion is 2015-06.
What conditions does trial NCT02284243 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT02284243?
The interventions under investigation include: Intranasal Dexmedetomidine (DRUG), Intranasal Placebo (DRUG).
Who is sponsoring clinical trial NCT02284243?
This trial is sponsored by Baudax Bio, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02284243 being conducted?
This trial has 3 study locations across California, 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 NCT02284243's enrollment target sits among peer trials
168 22nd of 113 higher than 92 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.
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