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NCT03068897 · ClinicalTrials.gov registry record · Phase 4
Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain
A Phase 4 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 320
- Enrollment target
NCT03068897: Completed Phase 4 study, sponsored by Montefiore Medical Center.
NCT03068897 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 320 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03068897, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 320 participants
- Enrollment target
Study Summary
This is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. Patients will be enrolled at the time of an emergency visit and followed for three months to determine outcomes.
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
- BEHAVIORAL Educational intervention
- DRUG Tizanidine
- DRUG Baclofen
- DRUG Metaxalone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2017-05-03 |
| Est. Completion | 2018-10-11 |
| Phase | Phase 4 |
What the finished NCT03068897 record still lists
NCT03068897 is an interventional study that assigns participants to a tested intervention. The registered 320 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 (38% lower).
The record links to 0 conditions, and to 5 interventions - of which Ibuprofen 600 mg is the first listed.
NCT03068897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03068897 about?
NCT03068897 is a clinical study titled "Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain". This is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. Patients will be enrolled at the time of an emergency visit and follow...
What is the current status of trial NCT03068897?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 320 participants. The study started on 2017-05-03. Estimated completion is 2018-10-11.
What interventions are being tested in trial NCT03068897?
The interventions under investigation include: Ibuprofen 600 mg (DRUG), Educational intervention (BEHAVIORAL), Tizanidine (DRUG), Baclofen (DRUG), Metaxalone (DRUG).
Who is sponsoring clinical trial NCT03068897?
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 NCT03068897's enrollment target sits among peer trials
320 259th of 2000 higher than 1,741 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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