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NCT04452344 · ClinicalTrials.gov registry record · Phase 3
Opioid Analgesic Reduction Study
A Phase 3 study of Opioid Use, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Phase 3
- Development phase
- 1,815
- Enrollment target
- 5
- Study locations
NCT04452344: Active Phase 3 study of Opioid Use, sponsored by Rutgers, The State University of New Jersey.
NCT04452344 is a Phase 3 study of Opioid Use that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 1,815 participants, below the 148,243-participant average among 105 other Opioid Use trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04452344, a Phase 3 study of Opioid Use, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,815 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the
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
| Field | Value |
|---|---|
| Enrollment Target | 1,815 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the registry record for NCT04452344 still lists
NCT04452344 is an interventional study that assigns participants to a tested intervention. Its 1,815 participants enrollment target places it among the larger protocols in the corpus, below the 148,243-participant average among 105 other Opioid Use trials with a reported enrollment target (99% lower).
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.
NCT04452344 lists 5 locations in 5 states (Illinois, Maryland, Michigan).
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.
What interventions are being tested in trial NCT04452344?
The interventions under investigation include: opioid-containing analgesic (DRUG), two over-the-counter analgesics (DRUG).
Who is sponsoring clinical trial NCT04452344?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04452344's enrollment target sits among peer trials
1,815 7th of 105 higher than 99 of 105 other Opioid Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use 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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