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NCT07595302 · ClinicalTrials.gov registry record · Phase 4
Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain
A Phase 4 study, sponsored by Montefiore Medical Center.
- Not yet
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
NCT07595302: Clinical Trial Phase 4 study, sponsored by Montefiore Medical Center.
NCT07595302 is a Phase 4 study that has not yet begun recruiting, run by Montefiore Medical Center. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07595302, a Phase 4 study, has not yet begun recruiting, sponsored by Montefiore Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
Study Summary
The investigator team proposes a randomized, double-blind, double-dummy comparative effectiveness trial conducted in two urban emergency departments (EDs) in the Bronx, New York. This study is designed to determine the relative efficacy of IV acetaminophen compared to PO acetaminophen in treating pelvic pain. This design focuses on the early onset of action and short-term efficacy, which may better capture potential differences between IV and PO acetaminophen in the acute ED setting.
Primary Outcome
Mean Change in NRS score will be assessed at 30 minutes post-treatment. The NRS is a patient self-assessment pain scale that instructs patients to use a facial grimace scale ranging from 0-10 rating to express pain intensity, wherein 0 is "No pain" and 10 is "Worst pain possible," such that higher scores are indicative of greater pain intensity. For purposes of the primary outcome change in NRS score from baseline will be assessed. Results will be summarized by study arm using descriptive statis
Interventions
- OTHER IV Placebo
- DRUG Acetaminophen 1000mg PO
- DRUG IV Acetaminophen 1000mg
- OTHER PO Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2026-07-30 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 4 |
What is known before NCT07595302 opens enrollment
NCT07595302 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which IV Placebo is the first listed.
NCT07595302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07595302 about?
NCT07595302 is a clinical study titled "Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain". The investigator team proposes a randomized, double-blind, double-dummy comparative effectiveness trial conducted in two urban emergency departments (EDs) in the Bronx, New York. This study is designed to determine the relative efficacy of IV acetaminophen compared to PO acetaminophen in treating pe...
What is the current status of trial NCT07595302?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2026-07-30. Estimated completion is 2027-06-30.
What interventions are being tested in trial NCT07595302?
The interventions under investigation include: IV Placebo (OTHER), Acetaminophen 1000mg PO (DRUG), IV Acetaminophen 1000mg (DRUG), PO Placebo (OTHER).
Who is sponsoring clinical trial NCT07595302?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07595302's enrollment target sits among peer trials
140 581st of 2000 higher than 1,408 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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