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NCT03554018 · ClinicalTrials.gov registry record · Phase 3
Ibuprofen With or Without Acetaminophen for Low Back Pain
A Phase 3 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT03554018: Completed Phase 3 study, sponsored by Montefiore Medical Center.
NCT03554018 is a Phase 3 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03554018, a Phase 3 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
Study Summary
This is a randomized clinical trial comparing two interventions for acute low back pain: 1. Ibuprofen + acetaminophen 2. Ibuprofen + placebo Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.
Primary Outcome
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ scor
Interventions
- DRUG Ibuprofen 600 mg
- DRUG Acetaminophen
- DRUG Placebo oral capsule
- BEHAVIORAL Educational intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 3 |
What the finished NCT03554018 record still lists
NCT03554018 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 4 interventions - of which Ibuprofen 600 mg is the first listed.
NCT03554018 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03554018 about?
NCT03554018 is a clinical study titled "Ibuprofen With or Without Acetaminophen for Low Back Pain". This is a randomized clinical trial comparing two interventions for acute low back pain: 1. Ibuprofen + acetaminophen 2. Ibuprofen + placebo Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time...
What is the current status of trial NCT03554018?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2018-10-16. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT03554018?
The interventions under investigation include: Ibuprofen 600 mg (DRUG), Acetaminophen (DRUG), Placebo oral capsule (DRUG), Educational intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03554018?
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 NCT03554018's enrollment target sits among peer trials
120 1619th of 2000 higher than 361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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