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NCT01230411 · ClinicalTrials.gov registry record · Phase 4
Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack
A Phase 4 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT01230411: Completed Phase 4 study, sponsored by Thomas Jefferson University.
NCT01230411 is a Phase 4 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01230411, a Phase 4 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in subjects who are treated with study medication between 2 and 72 hours from time of onset of headache. Periodic safety and efficacy assessments will be performed prior to and after study drug administration. Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment groups (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.
Primary Outcome
Comparison of proportion of subjects in each treatment group (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.
Interventions
- DRUG Ibuprofen
- OTHER saline placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-06 |
| Est. Completion | 2017-07 |
| Phase | Phase 4 |
What the finished NCT01230411 record still lists
NCT01230411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibuprofen is the first listed.
NCT01230411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01230411 about?
NCT01230411 is a clinical study titled "Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack". This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in subjects who are treated with study medication between 2 and 72 hours from time of onset of headache. Periodic safety and ...
What is the current status of trial NCT01230411?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2011-06. Estimated completion is 2017-07.
What interventions are being tested in trial NCT01230411?
The interventions under investigation include: Ibuprofen (DRUG), saline placebo (OTHER).
Who is sponsoring clinical trial NCT01230411?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01230411's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 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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