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COMPLETED Phase 2

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery

NCT02284243 · View on ClinicalTrials.gov ↗

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

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02284243

The ClinicalTrials.gov registry entry for NCT02284243 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baudax Bio, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02284243 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02284243?

The interventions under investigation include: Intranasal Dexmedetomidine (DRUG), Intranasal Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02284243?

This trial is sponsored by Baudax Bio, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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