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NCT00330343 · ClinicalTrials.gov registry record · Phase 2
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT00330343: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT00330343 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00330343, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute, moderate to severe pain, and who are to be treated with intravenous Patient controlled analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of patients will be post operative patients, and will start therapy and the investigational drug in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan on studying between 10 and 99, male and female patients over a 2 year period.
Interventions
- DRUG naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-05 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00330343
The ClinicalTrials.gov registry entry for NCT00330343 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which naloxone is the first listed.
NCT00330343 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00330343 about?
NCT00330343 is a clinical study titled "Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents". This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the Johns Hopkins Hospital, who...
What is the current status of trial NCT00330343?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2004-05. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00330343?
The interventions under investigation include: naloxone (DRUG).
Who is sponsoring clinical trial NCT00330343?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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