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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 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.

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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.

Conditions Studied

Interventions

  • DRUG H2O
  • DRUG 1+1

Study Locations (1)

New York

  • Montefiore Medical Center Moses Division Emergency Department - The Bronx

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2011-01
Est. Completion 2011-11
Phase Phase 3

Sponsor

Montefiore Medical Center

345 total trials

What the Registry Record Tells You About NCT01311895

The ClinicalTrials.gov registry entry for NCT01311895 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 261-participant average among 50 other Acute Pain trials with a reported enrollment target (34% higher). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.