Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01097304
First received: March 31, 2010
Last updated: April 29, 2015
Last verified: October 2014
Results First Received: April 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Barrett Esophagus
Esophageal Carcinoma
Interventions: Drug: Ursodiol
Other: Laboratory Biomarker Analysis

  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
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Reporting Groups
  Description
Treatment (Ursodiol)

Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.

Ursodiol: Given PO

Laboratory Biomarker Analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Ursodiol)  
STARTED     36  
COMPLETED     29  
NOT COMPLETED     7  



  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
Treatment (Ursodiol)

Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.

Ursodiol: Given PO

Laboratory Biomarker Analysis: Correlative studies


Baseline Measures
    Treatment (Ursodiol)  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     16  
Age  
[units: years]
Mean (Standard Deviation)
  62.8  (10.4)  
Gender  
[units: participants]
 
Female     6  
Male     30  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures

1.  Primary:   Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining   [ Time Frame: Baseline to 6 months ]

2.  Secondary:   Changes in Gastric Bile Acid Composition, Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention   [ Time Frame: Baseline and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Changes in Cell Proliferation in BE Epithelium From Baseline to Post-intervention as Assessed by Proliferation-related Ki-67 Antigen (Ki67) Immunostaining, Percentage of Positively Stained Nuclei, in BE Tissue Sections   [ Time Frame: Baseline and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sherry Chow
Organization: University of Arizona
phone: 520-626-3358
e-mail: schow@azcc.arizona.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01097304     History of Changes
Other Study ID Numbers: NCI-2012-00450, NCI-2012-00450, CDR0000669111, 09-0141-03, UAZ08-11-01, P50CA095060, N01CN35158, P30CA023074
Study First Received: March 31, 2010
Results First Received: April 29, 2015
Last Updated: April 29, 2015
Health Authority: United States: Food and Drug Administration