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NCT04122443 · ClinicalTrials.gov registry record · Phase 4
Acetaminophen (APAP) +/- Oxycodone
A Phase 4 study of Musculoskeletal Pain, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 393
- Enrollment target
- 1
- Study location
NCT04122443: Completed Phase 4 study of Musculoskeletal Pain, sponsored by Montefiore Medical Center.
NCT04122443 is a Phase 4 study of Musculoskeletal Pain that has completed, run by Montefiore Medical Center. The registered enrollment target is 393 participants, above the 145-participant average among 37 other Musculoskeletal Pain trials with a reported enrollment target (171% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04122443, a Phase 4 study of Musculoskeletal Pain, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 393 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen
Primary Outcome
Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
Conditions Studied
Interventions
- DRUG Acetaminophen
- DRUG Oxycodone
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2022-07-31 |
| Phase | Phase 4 |
What the finished NCT04122443 record still lists
NCT04122443 is an interventional study that assigns participants to a tested intervention. The registered 393 participants enrollment target is mid-sized for trials with a published cap, above the 145-participant average among 37 other Musculoskeletal Pain trials with a reported enrollment target (171% higher).
The record links to 1 condition, with Musculoskeletal Pain appearing as the primary indexed condition, and to 2 interventions - of which Acetaminophen is the first listed.
NCT04122443 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04122443 about?
NCT04122443 is a clinical study titled "Acetaminophen (APAP) +/- Oxycodone". This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen
What is the current status of trial NCT04122443?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 393 participants. The study started on 2019-12-01. Estimated completion is 2022-07-31.
What conditions does trial NCT04122443 study?
This clinical trial studies the following conditions: Musculoskeletal Pain.
What interventions are being tested in trial NCT04122443?
The interventions under investigation include: Acetaminophen (DRUG), Oxycodone (DRUG).
Who is sponsoring clinical trial NCT04122443?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04122443 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Musculoskeletal Pain
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 NCT04122443's enrollment target sits among peer trials
393 4th of 37 higher than 34 of 37 other Musculoskeletal Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Musculoskeletal Pain 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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