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NCT01311895 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
A Phase 3 study of Acute Pain, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 1
- Study location
NCT01311895: Completed Phase 3 study of Acute Pain, sponsored by Montefiore Medical Center.
NCT01311895 is a Phase 3 study of Acute Pain that has completed, run by Montefiore Medical Center. The registered enrollment target is 350 participants, above the 261-participant average among 50 other Acute Pain trials with a reported enrollment target (34% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01311895, a Phase 3 study of Acute Pain, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.
Primary Outcome
The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.
Conditions Studied
Interventions
- DRUG H2O
- DRUG 1+1
Study Locations (1)
New York
- Montefiore Medical Center Moses Division Emergency Department - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01311895 record still lists
NCT01311895 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 261-participant average among 50 other Acute Pain trials with a reported enrollment target (34% higher).
The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 2 interventions - of which H2O is the first listed.
NCT01311895 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01311895 about?
NCT01311895 is a clinical study titled "Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone". The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21...
What is the current status of trial NCT01311895?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2011-01. Estimated completion is 2011-11.
What conditions does trial NCT01311895 study?
This clinical trial studies the following conditions: Acute Pain.
What interventions are being tested in trial NCT01311895?
The interventions under investigation include: H2O (DRUG), 1+1 (DRUG).
Who is sponsoring clinical trial NCT01311895?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01311895 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 Acute Pain
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 NCT01311895's enrollment target sits among peer trials
350 8th of 50 higher than 43 of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain 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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