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Trial record 2 of 7 for:    "Albrights hereditary osteodystrophy"

Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)

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ClinicalTrials.gov Identifier: NCT02463409
Recruitment Status : Completed
First Posted : June 4, 2015
Results First Posted : May 30, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Ashley Shoemaker, Vanderbilt University Medical Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pseudohypoparathyroidism Type 1a
Albright Hereditary Osteodystrophy
Intervention: Drug: Theophylline

  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
The screening visit included labs, physical exam and medical history, prior to assignment to the theophylline arm.

Reporting Groups
  Description
Theophylline

Patients will receive a 24 hour continuous infusion of intravenous theophylline.

Theophylline: 24 hour infusion of IV theophylline


Participant Flow:   Overall Study
    Theophylline
STARTED   6 
COMPLETED   4 
NOT COMPLETED   2 
Withdrawal by Subject                1 
Screen failure                1 



  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 patients who enrolled in the study, not including screen fails

Reporting Groups
  Description
Theophylline

Patients will receive a 24 hour continuous infusion of intravenous theophylline.

Theophylline: 24 hour infusion of IV theophylline


Baseline Measures
   Theophylline 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.4  (3.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   5 
Male   0 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      5 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

1.  Primary:   Change in Urine cAMP   [ Time Frame: 1 day ]

2.  Secondary:   Change in Resting Energy Expenditure (REE)   [ Time Frame: 1 day ]

3.  Secondary:   Change in Apnea Hypopnea Index (AHI)   [ Time Frame: 1 day ]


  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: Dr. Ashley Shoemaker
Organization: Vanderbilt University Medical Center
phone: 615-343-8816 ext 615
e-mail: ashley.h.shoemaker@vanderbilt.edu


Publications:

Responsible Party: Ashley Shoemaker, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02463409     History of Changes
Other Study ID Numbers: IRB 150497
First Submitted: May 20, 2015
First Posted: June 4, 2015
Results First Submitted: April 19, 2017
Results First Posted: May 30, 2017
Last Update Posted: June 26, 2017