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NCT01380197 · ClinicalTrials.gov registry record · Phase 3

Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally

A Phase 3 study, sponsored by Children's Healthcare of Atlanta.

Completed
Registry status
Phase 3
Development phase
40
Enrollment target

NCT01380197: Completed Phase 3 study, sponsored by Children's Healthcare of Atlanta.

NCT01380197 is a Phase 3 study that has completed, run by Children's Healthcare of Atlanta. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01380197, a Phase 3 study, has completed, sponsored by Children's Healthcare of Atlanta.

COMPLETED
Registry status
Phase 3
Development phase
40 participants
Enrollment target

Study Summary

The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects. The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.

Primary Outcome

Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray

Interventions

  • DRUG Morphine
  • DRUG Nubain

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2010-05-26
Est. Completion 2016-10-18
Phase Phase 3
Children's Healthcare of Atlanta

80 total trials

What the finished NCT01380197 record still lists

NCT01380197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).

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

NCT01380197 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01380197 about?

NCT01380197 is a clinical study titled "Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally". The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia cau...

What is the current status of trial NCT01380197?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2010-05-26. Estimated completion is 2016-10-18.

What interventions are being tested in trial NCT01380197?

The interventions under investigation include: Morphine (DRUG), Nubain (DRUG).

Who is sponsoring clinical trial NCT01380197?

This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01380197's enrollment target sits among peer trials

40 1878th of 2000 higher than 103 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 NCT01380197, the US trial registry maintained by the National Library of Medicine. NCT01380197 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.