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Trial record 5 of 14 for:    "Job syndrome" OR "Job's Syndrome"

Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome

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ClinicalTrials.gov Identifier: NCT00527878
Recruitment Status : Terminated (Failure to enroll adequate patient numbers due to small number of eligible patients)
First Posted : September 11, 2007
Results First Posted : February 4, 2013
Last Update Posted : February 4, 2013
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: JOB's Syndrome
Hyper-IgE Recurrent Infection Syndrome
Immune Deficiency
Interventions: Drug: Ranitidine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
16 participants were screened but only 14 participants were randomized. Two individuals decided not to participate.

Reporting Groups
  Description
Placebo/Ranitidine Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive placebo for 12 months followed by 12 months of the ranitidine.
Ranitidine/Placebo Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive ranitidine for 12 months followed by 12 months of the ranitidine.

Participant Flow for 2 periods

Period 1:   Intervention 1
    Placebo/Ranitidine   Ranitidine/Placebo
STARTED   7   7 
COMPLETED   5   4 
NOT COMPLETED   2   3 

Period 2:   Intervention 2
    Placebo/Ranitidine   Ranitidine/Placebo
STARTED   5   4 
COMPLETED   5   4 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants whether or not they were randomized.

Reporting Groups
  Description
Patients No text entered.

Baseline Measures
   Patients 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
 
<=18 years   6 
Between 18 and 65 years   10 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.2  (13.6) 
Gender 
[Units: Participants]
 
Female   8 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures

1.  Primary:   Number of Infections in Subjects With HIES.   [ Time Frame: 1 year on intervention ]

2.  Secondary:   New Skin Infections   [ Time Frame: 12 months placebo/12 months ranitidine ]

3.  Secondary:   New Lung Infections   [ Time Frame: 12 months placebo and 12 months ranitidine ]

4.  Secondary:   Clinical Severity Score   [ Time Frame: one year on ranitidine and one year on placebo ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alexandra Freeman MD, Staff Clinician, Lead Associate Investigator for Protocol
Organization: NIAID, NIH
phone: 301-594-9045
e-mail: freemaal@mail.nih.gov


Publications:

Responsible Party: Steven M. Holland, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00527878     History of Changes
Other Study ID Numbers: 070218
07-I-0218
First Submitted: September 8, 2007
First Posted: September 11, 2007
Results First Submitted: February 1, 2013
Results First Posted: February 4, 2013
Last Update Posted: February 4, 2013