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NCT00263562 · ClinicalTrials.gov registry record · Phase 3
Steroid Treatment for Sickle Cell Pain Crisis
A Phase 3 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT00263562 is a Phase 3 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 18 participants.
The verdict
NCT00263562, a Phase 3 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
The painful episode is the most common problem experienced by children with sickle cell disease. Although various treatments are available during painful episodes, the medication most commonly given for pain is a pain medication such as morphine. Fluids are also used. Even with these treatments, many children still have severe pain that is difficult to control. In addition to pain medications, there are other medications that may be useful. Methylprednisolone (solumedrol) and prednisone are a group of medications called steroids that may be helpful for painful episodes. These medications are known to lower the amount of inflammation (this means swelling, tenderness, and soreness) in the body. Because this medication may help with your pain, you are being asked to be a part of this study. These types of medications are used in other illnesses such as asthma, especially during times when the illness has gotten worse. The main purpose of this study is to see if the methylprednisolone and prednisone will lower the amount of pain and the length of hospital stay. In addition to the pain medication you will normally receive, you will be assigned to one of 2 groups: 1) the experimental group with the active form of the medicine, or 2) a comparison group without the active form of the medicine. In either group, you will still receive all of the treatments you would normally receive for a painful episode, including pain medicines and fluids. You and your doctors will not know what group you will be assigned. If you decide to be a part of the study the following will happen: For the first 5 days, you will be asked to: 1) describe your current pain (0=no pain to 10=a lot of pain), worst pain (0=no pain to 10=a lot of pain), least pain (0=no pain to 10=a lot of pain), and the amount of pain relief (0=no relief to 10=complete relief); 2) describe any signs or symptoms you feel, including filling out a pain scale form each day; 3) and take the medicines for 5 days, either at h
Interventions
- OTHER Placebo
- DRUG Steroid arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2005-12-01 |
| Est. Completion | 2008-06-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00263562
The ClinicalTrials.gov registry entry for NCT00263562 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00263562 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00263562 about?
NCT00263562 is a clinical study titled "Steroid Treatment for Sickle Cell Pain Crisis". The painful episode is the most common problem experienced by children with sickle cell disease. Although various treatments are available during painful episodes, the medication most commonly given for pain is a pain medication such as morphine. Fluids are also used. Even with these treatments, man...
What is the current status of trial NCT00263562?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2005-12-01. Estimated completion is 2008-06-13.
What interventions are being tested in trial NCT00263562?
The interventions under investigation include: Placebo (OTHER), Steroid arm (DRUG).
Who is sponsoring clinical trial NCT00263562?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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