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NCT00627367 · ClinicalTrials.gov registry record · Phase 3

Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain

A Phase 3 study, sponsored by Montefiore Medical Center.

Completed
Registry status
Phase 3
Development phase
224
Enrollment target

NCT00627367: Completed Phase 3 study, sponsored by Montefiore Medical Center.

NCT00627367 is a Phase 3 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 224 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00627367, a Phase 3 study, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
Phase 3
Development phase
224 participants
Enrollment target

Study Summary

Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and no more adverse events than patients receiving non-protocolized pain management.

Primary Outcome

Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department).

Interventions

  • DRUG Hydromorphone
  • DRUG Nonprotocolized

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2007-12
Est. Completion 2008-03
Phase Phase 3
Montefiore Medical Center

345 total trials

What the finished NCT00627367 record still lists

NCT00627367 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 2 interventions - of which Hydromorphone is the first listed.

NCT00627367 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00627367 about?

NCT00627367 is a clinical study titled "Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain". Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and no more adverse events than patients receiving non-protocolized pain management.

What is the current status of trial NCT00627367?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 224 participants. The study started on 2007-12. Estimated completion is 2008-03.

What interventions are being tested in trial NCT00627367?

The interventions under investigation include: Hydromorphone (DRUG), Nonprotocolized (DRUG).

Who is sponsoring clinical trial NCT00627367?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00627367's enrollment target sits among peer trials

224 1317th of 2000 higher than 684 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00627367, the US trial registry maintained by the National Library of Medicine. NCT00627367 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.