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Oral Peanut Immunotherapy (PNOIT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wayne G. Shreffler MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01324401
First received: August 12, 2010
Last updated: November 23, 2016
Last verified: November 2016
Results First Received: November 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peanut Allergy
Intervention: Drug: Peanut flour OIT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control - Crossover The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
Peanut OIT Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.

Participant Flow:   Overall Study
    Control - Crossover   Peanut OIT
STARTED   4   26 
COMPLETED   3   19 
NOT COMPLETED   1   7 
Physician Decision                0                2 
Withdrawal by Subject                1                3 
Screen Fail                0                2 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Control - Crossover The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will have the opportunity to cross over to active therapy.
Peanut OIT Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Total Total of all reporting groups

Baseline Measures
   Control - Crossover   Peanut OIT   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   26   30 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      4 100.0%      26 100.0%      30 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
     
Female      1  25.0%      11  42.3%      12  40.0% 
Male      3  75.0%      15  57.7%      18  60.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      2   7.7%      2   6.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      3  75.0%      23  88.5%      26  86.7% 
More than one race      1  25.0%      1   3.8%      2   6.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   4   26   30 


  Outcome Measures
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1.  Primary:   Tolerance   [ Time Frame: at least 36 months ]

2.  Secondary:   Desensitization   [ Time Frame: at least 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wayne Shreffler
Organization: Harvard Medical School / Massachusetts General Hospital
phone: 617-726-6147
e-mail: wshreffler@mgh.harvard.edu



Responsible Party: Wayne G. Shreffler MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01324401     History of Changes
Other Study ID Numbers: 2010P000609
Study First Received: August 12, 2010
Results First Received: November 23, 2016
Last Updated: November 23, 2016