Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome
Stopped early · Phase 2 · Has a placebo group
Conditions studied: JOB's Syndrome, Hyper-IgE Recurrent Infection Syndrome, Immune Deficiency
In brief
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.
Key facts
- Study ID
- NCT00527878
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 16
- Starts
- 2007-09-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2013-02-04
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Pregnancy. Ranitidine is pregnancy class B, and likely safe in pregnancy, but as this has not been studied, pregnant patients will be excluded. In addition, hormonal changes that occur during pregnancy may affect the skin manifestations and frequency of infection.
- Hypersensitivity to ranitidine or any of the ingredients in ranitidine.
- Pre-existing medications or conditions for which the investigators judge that ranitidine should not be given.
- Patient or investigators unwilling to stop baseline H2 receptor antagonist therapy (over the counter or prescription) such as Tagamet (Cimetidine), Pepcid (Famotidine), and Axid (Nizatidine). H2 receptor antagonist therapy must be stopped for 3 months prior to study initiation. Patients who are receiving H2 receptor antagonist therapy for gastritis, acid reflux, or peptic ulcer disease will be offered changing their regimen to a proton pump inhibitor or other non-H2 receptor antagonist therapy to allow for study enrollment (3 months after stopping the H2 receptor antagonist).
- Patients under the age of 2 years
- Patients with HIV, receiving chemotherapy or who have a malignancy.
- Any condition that in the judgment of the investigator would place the subject at undue risk or compromise the results or interpretation of the study.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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