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NCT02389829 · ClinicalTrials.gov registry record · Phase 4
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
A Phase 4 study of Migraine, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 127
- Enrollment target
- 1
- Study location
NCT02389829: Completed Phase 4 study of Migraine, sponsored by Montefiore Medical Center.
NCT02389829 is a Phase 4 study of Migraine that has completed, run by Montefiore Medical Center. The registered enrollment target is 127 participants, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02389829, a Phase 4 study of Migraine, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 127 participants
- Enrollment target
- 1
- Study location
Study Summary
Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.
Primary Outcome
Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours, without use of addition medication. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.
Conditions Studied
Interventions
- DRUG Hydromorphone
- DRUG Diphenhydramine
- DRUG Prochlorperazine
Study Locations (1)
New York
- Montefiore Medical Center--Einstein - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-10 |
| Phase | Phase 4 |
What the finished NCT02389829 record still lists
NCT02389829 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 3 interventions - of which Hydromorphone is the first listed.
NCT02389829 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02389829 about?
NCT02389829 is a clinical study titled "Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine". Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to...
What is the current status of trial NCT02389829?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2015-03. Estimated completion is 2016-10.
What conditions does trial NCT02389829 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT02389829?
The interventions under investigation include: Hydromorphone (DRUG), Diphenhydramine (DRUG), Prochlorperazine (DRUG).
Who is sponsoring clinical trial NCT02389829?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02389829 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02389829's enrollment target sits among peer trials
127 52nd of 102 higher than 51 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine 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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