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NCT05851976 · ClinicalTrials.gov registry record · Phase 4
Duloxetine for LBP
A Phase 4 study of Back Pain, Low, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05851976: Recruiting Phase 4 study of Back Pain, Low, sponsored by Montefiore Medical Center.
NCT05851976 is a Phase 4 study of Back Pain, Low that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 120 participants, below the 237-participant average among 5 other Back Pain, Low trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05851976, a Phase 4 study of Back Pain, Low, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.
Primary Outcome
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used to assess LBP. Study participants will be asked to describe their worst back pain over the previous 24 hours. The number of patients reporting with "Moderate" or "Severe" pain will be summarized by study arm.
Conditions Studied
Interventions
- DRUG Duloxetine
- DRUG Naproxen
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-10-04 |
| Est. Completion | 2027-05 |
| Phase | Phase 4 |
What NCT05851976 shows while recruiting
NCT05851976 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 237-participant average among 5 other Back Pain, Low trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Back Pain, Low appearing as the primary indexed condition, and to 2 interventions - of which Duloxetine is the first listed.
NCT05851976 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05851976 about?
NCT05851976 is a clinical study titled "Duloxetine for LBP". This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine c...
What is the current status of trial NCT05851976?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2023-10-04. Estimated completion is 2027-05.
What conditions does trial NCT05851976 study?
This clinical trial studies the following conditions: Back Pain, Low.
What interventions are being tested in trial NCT05851976?
The interventions under investigation include: Duloxetine (DRUG), Naproxen (DRUG).
Who is sponsoring clinical trial NCT05851976?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05851976 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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