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NCT00527878 · ClinicalTrials.gov registry record · Phase 2
Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00527878 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 16 participants.
The verdict
NCT00527878, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of ranitidine (Zantac) in patients with Hyper-IgE recurrent infection syndrome, a disease characterized by recurrent infections of the ears, sinuses, lungs and skin, and abnormal levels of the antibody immunoglobulin E (IgE). Patients age 2 and older who have Hyper-IgE recurrent infection syndrome and who have had chronic or frequent infections in the last 12 months may be eligible for this study. Participants are randomly assigned to take ranitidine or placebo in pill or liquid form twice a day for 12 months. In addition to treatment, patients undergo the following procedures during visits scheduled on day 0 of the study (baseline) and at 3, 12, 15 and 24 months. Evaluations at 6, 9, 18 and 21 months are by telephone. * Medical history and physical examination - baseline and 3 and 24 months. * Clinical severity score - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months. * Dermatology exam - baseline and 3, 12, 15 and 24 months. * Pulmonary function test - baseline and 12 and 24 months. * Chest CT - baseline and 12 and 24 months. * Quality of life assessment - baseline and 3, 12, 15 and 24 months. * Pregnancy testing - baseline and 3, 12, 15 and 24 months. * HIV test - baseline and 12 and 24 months. * Contraception evaluation - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months. * Missed school/work days assessment - baseline and 3, 12, 15 and 24 months. * Medication adherence - baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months. In addition to the above procedures, participants who are not enrolled in study 00-I-0159 have a baseline scoliosis series and genetic consult.
Interventions
- DRUG Placebo
- DRUG Ranitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00527878
The ClinicalTrials.gov registry entry for NCT00527878 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00527878 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00527878 about?
NCT00527878 is a clinical study titled "Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome". This study will examine the safety and effectiveness of ranitidine (Zantac) in patients with Hyper-IgE recurrent infection syndrome, a disease characterized by recurrent infections of the ears, sinuses, lungs and skin, and abnormal levels of the antibody immunoglobulin E (IgE). Patients age 2 and o...
What is the current status of trial NCT00527878?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2007-09. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00527878?
The interventions under investigation include: Placebo (DRUG), Ranitidine (DRUG).
Who is sponsoring clinical trial NCT00527878?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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