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Oral Immunotherapy (OIT) for Peanut Allergy (PnOIT3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00815035
First received: December 26, 2008
Last updated: July 26, 2017
Last verified: July 2017
Results First Received: March 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Peanut Hypersensitivity
Interventions: Drug: Peanut OIT
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Blinded Phase-Peanut OIT

Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.

Peanut OIT: Peanut flour that is orally ingested in a graded fashion.

Blinded Phase-Placebo

Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.

Placebo: Oat flour used as a placebo that is orally ingested a graded fashion

Open Label Phase-Peanut OIT

Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.

Peanut OIT: Peanut flour that is orally ingested in a graded fashion.


Participant Flow for 2 periods

Period 1:   Blinded Phase
    Blinded Phase-Peanut OIT   Blinded Phase-Placebo   Open Label Phase-Peanut OIT
STARTED   10   6   0 
COMPLETED   9   6   0 
NOT COMPLETED   1   0   0 

Period 2:   Open Label Extension Phase
    Blinded Phase-Peanut OIT   Blinded Phase-Placebo   Open Label Phase-Peanut OIT
STARTED   0 [1]   0 [1]   15 [1] 
COMPLETED   0   0   9 
NOT COMPLETED   0   0   6 
[1] After unblinding, subjects completing the blinded phase moved to the open-label phase of the study



  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.
No text entered.

Reporting Groups
  Description
Blinded Phase-Peanut OIT

Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.

Peanut OIT: Peanut flour that is orally ingested in a graded fashion.

Blinded Phase-Placebo

Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.

Placebo: Oat flour used as a placebo that is orally ingested a graded fashion

Total Total of all reporting groups

Baseline Measures
   Blinded Phase-Peanut OIT   Blinded Phase-Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   6   16 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      10 100.0%      6 100.0%      16 100.0% 
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% 
Age 
[Units: Years]
Mean (Full Range)
 5.1 
 (3.8 to 6.9) 
 4.8 
 (3.6 to 6.9) 
 5.0 
 (3.6 to 6.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  60.0%      4  66.7%      10  62.5% 
Male      4  40.0%      2  33.3%      6  37.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      10 100.0%      6 100.0%      16 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
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%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  10.0%      0   0.0%      1   6.3% 
White      8  80.0%      4  66.7%      12  75.0% 
More than one race      1  10.0%      2  33.3%      3  18.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   6   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy.   [ Time Frame: 61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy ]

2.  Secondary:   The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy.   [ Time Frame: 60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy ]

3.  Secondary:   The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut   [ Time Frame: first day of peanut OIT dosing ]

4.  Secondary:   The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study   [ Time Frame: approximately 40 weeks (10 months) ]

5.  Secondary:   Incidence of All Serious Adverse Events During the Study   [ Time Frame: 61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study. ]


  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: Edwin Kim, Director UNC Food Allergy Initiative
Organization: University of North Carolina at Chapel Hill
phone: 919-843-9087
e-mail: edwinkim@email.unc.edu


Publications:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00815035     History of Changes
Other Study ID Numbers: 11-2315
Study First Received: December 26, 2008
Results First Received: March 27, 2017
Last Updated: July 26, 2017