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Domperidone for Gastroparesis in Solid Organ Transplantation

This study has been terminated.
(Lack of perceived need for domperidone in this population)
Sponsor:
Information provided by (Responsible Party):
David J. Lederer, M.D., Columbia University
ClinicalTrials.gov Identifier:
NCT00552422
First received: October 31, 2007
Last updated: June 17, 2015
Last verified: June 2015
Results First Received: June 2, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Gastroparesis
Gastroesophageal Reflux
Intervention: Drug: domperidone

  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
Domperidone Arm

Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day.

domperidone: 10mg orally four times per day


Participant Flow:   Overall Study
    Domperidone Arm
STARTED   6 
COMPLETED   6 
NOT COMPLETED   0 



  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
Domperidone Arm

Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day.

domperidone: 10mg orally four times per day


Baseline Measures
   Domperidone Arm 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age, Customized 
[Units: Participants]
 
18-65   6 
Gender 
[Units: Participants]
 
Female   4 
Male   2 


  Outcome Measures

1.  Primary:   Symptomatic Improvement   [ Time Frame: 2 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
No text entered.


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


Results Point of Contact:  
Name/Title: David Lederer
Organization: Columbia University
phone: 212-342-4167
e-mail: tjb2134@cumc.columbia.edu



Responsible Party: David J. Lederer, M.D., Columbia University
ClinicalTrials.gov Identifier: NCT00552422     History of Changes
Other Study ID Numbers: AAAC3728
Study First Received: October 31, 2007
Results First Received: June 2, 2015
Last Updated: June 17, 2015
Health Authority: United States: Food and Drug Administration