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Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises
NCT00094887 · View on ClinicalTrials.gov ↗
Study Summary
This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells. Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart. Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease. For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nitric Oxide
Study Locations (11)
Maryland
- Johns Hopkins University — Baltimore
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Massachusetts
- Brigham and Women's Hospital — Boston
- Childrens Hospital, Boston — Boston
Pennsylvania
- St. Christopher's Hospital for Children — Philadelphia
- Childrens Hospital, Pittsburgh — Pittsburgh
Alabama
- University of Alabama — Birmingham
California
- Children's Hospital Oakland — Oakland
Colorado
- Colorado Sickle Cell Treatement and Research Center — Aurora
District of Columbia
- Howard University Hospital — Washington D.C.
Ohio
- Case Western Reserve University Hospital — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00094887
The ClinicalTrials.gov registry entry for NCT00094887 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Anemia, Sickle Cell appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00094887 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Maryland, Massachusetts, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00094887 about?
NCT00094887 is a clinical study titled "Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises". This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. ...
What is the current status of trial NCT00094887?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2004-10. Estimated completion is 2008-12.
What conditions does trial NCT00094887 study?
This clinical trial studies the following conditions: Anemia, Sickle Cell. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00094887?
The interventions under investigation include: Placebo (DRUG), Nitric Oxide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00094887?
This trial is sponsored by Mallinckrodt, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00094887 being conducted?
This trial has 11 study locations across Alabama, California, Colorado, District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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