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ACTIVE NOT RECRUITING Phase 3

Opioid Analgesic Reduction Study

NCT04452344 · View on ClinicalTrials.gov ↗

Study Summary

The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results. This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.

Conditions Studied

Interventions

  • DRUG opioid-containing analgesic
  • DRUG two over-the-counter analgesics

Study Locations (5)

Illinois

  • University of Illinois at Chicago — Chicago

Maryland

  • University of Maryland — Baltimore

Michigan

  • University of Michigan — Ann Arbor

New Jersey

  • Rutgers School of Dental Medicine — Newark

New York

  • University of Rochester — Rochester

Trial Details

FieldValue
Enrollment Target 1,815 participants
Start Date 2021-01-04
Est. Completion 2025-12-31
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04452344

The ClinicalTrials.gov registry entry for NCT04452344 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 1,815 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 603 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 Opioid Use appearing as the primary indexed condition, and to 2 interventions — of which opioid-containing analgesic 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: NCT04452344 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Illinois, Maryland, Michigan. 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 NCT04452344 about?

NCT04452344 is a clinical study titled "Opioid Analgesic Reduction Study". The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that...

What is the current status of trial NCT04452344?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,815 participants. The study started on 2021-01-04. Estimated completion is 2025-12-31.

What conditions does trial NCT04452344 study?

This clinical trial studies the following conditions: Opioid Use. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04452344?

The interventions under investigation include: opioid-containing analgesic (DRUG), two over-the-counter analgesics (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04452344?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04452344 being conducted?

This trial has 5 study locations across Illinois, Maryland, Michigan, New Jersey, New York. 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