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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, Post Operative, sponsored by Baudax Bio.

Completed
Registry status
Phase 2
Development phase
168
Enrollment target
3
Study locations

NCT02284243 is a Phase 2 study of Pain, Post Operative that has completed, run by Baudax Bio. The registered enrollment target is 168 participants, below the 308-participant average among 4 other Pain, Post Operative trials with a reported enrollment target (45% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT02284243, a Phase 2 study of Pain, Post Operative, 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.

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

FieldValue
Enrollment Target 168 participants
Start Date 2014-10
Est. Completion 2015-06
Phase Phase 2

Sponsor

Baudax Bio

11 total trials

What the Registry Record Tells You About NCT02284243

The ClinicalTrials.gov registry entry for NCT02284243 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 308-participant average among 4 other Pain, Post Operative trials with a reported enrollment target (45% lower). The listed sponsor is Baudax Bio, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pain, Post Operative appearing as the primary indexed condition, and to 2 interventions - of which Intranasal Dexmedetomidine is the first listed.

NCT02284243 reports 3 study locations spanning 2 distinct geographic areas - top geographies include 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, Post Operative.

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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.