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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097304
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : May 15, 2015
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Barrett Esophagus
Esophageal Carcinoma
Interventions Drug: Ursodiol
Other: Laboratory Biomarker Analysis
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Ursodiol)
Hide Arm/Group Description

Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.

Ursodiol: Given PO

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 36
Completed 29
Not Completed 7
Arm/Group Title Treatment (Ursodiol)
Hide Arm/Group Description

Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.

Ursodiol: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  55.6%
>=65 years
16
  44.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
62.8  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
6
  16.7%
Male
30
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining
Hide Description 8OHdG will be assessed by percentage of positively stained nuclear area. A paired t-test at a one-sided 0.05 significance level will be used to assess change during intervention. The observed results will be reported along with the corresponding confidence intervals.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
participants with fewer than 500 total nuclei in longitudinally sectioned crypts opening to the lumen were excluded from analysis
Arm/Group Title Treatment (Ursodiol)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: % of strongly/moderately stained nuclei
1.62  (13.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Ursodiol)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Changes in Gastric Bile Acid Composition (Change in Percent of Total Bile Acid Present as Ursodeoxycholic Acid and Its Glycine/Taurine Conjugates) Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention
Hide Description [Not Specified]
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
analysis was limited to participants with baseline and 6-month gastric fluid
Arm/Group Title Treatment (Ursodiol)
Hide Arm/Group Description:

Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.

Ursodiol: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 28
Median (Inter-Quartile Range)
Unit of Measure: % of total bile acid
66.28
(36.29 to 77.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Ursodiol)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method signed rank test
Comments [Not Specified]
3.Secondary Outcome
Title Changes in Gastric Bile Acid Composition (Change in Percent of Total Bile Acid Present as Deoxycholic Acid and Its Glycine/Taurine Conjugates) Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention
Hide Description [Not Specified]
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
analysis was limited to participants with baseline and 6-month gastric fluid
Arm/Group Title Treatment (Ursodiol)
Hide Arm/Group Description:

Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.

Ursodiol: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 28
Median (Inter-Quartile Range)
Unit of Measure: % of total bile acid
-13.31
(-46.98 to 0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Ursodiol)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method signed rank test
Comments [Not Specified]
4.Secondary Outcome
Title 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
Hide Description Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
tissue slides with fewer than 500 total nuclei in longitudinally sectioned crypts opening to the lumen were excluded from analysis
Arm/Group Title Treatment (Ursodiol)
Hide Arm/Group Description:

Patients receive ursodiol PO (13 to 15 mg/kg/day) BID for 6 months in the absence of disease progression or unacceptable toxicity.

Ursodiol: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: % change
1.36  (13.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Ursodiol)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Ursodiol)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Ursodiol)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Treatment (Ursodiol)
Affected / at Risk (%)
Total   5/36 (13.89%) 
Cardiac disorders   
Hypotension  1/36 (2.78%) 
Ischemia/Infarction  1/36 (2.78%) 
Atrial Fibrillation  1/36 (2.78%) 
Chest/Thorax pain  1/36 (2.78%) 
Gastrointestinal disorders   
Enteritis  1/36 (2.78%) 
Barrett's esophagus with at least intramucosal carcinoma  1/36 (2.78%) 
Pancreatitis  1/36 (2.78%) 
Musculoskeletal and connective tissue disorders   
Post surgical pain  1/36 (2.78%) 
Nervous system disorders   
CNS cerebrovascular ischemia  1/36 (2.78%) 
Altered mental status  1/36 (2.78%) 
Renal and urinary disorders   
Renal failure  1/36 (2.78%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Ursodiol)
Affected / at Risk (%)
Total   31/36 (86.11%) 
Cardiac disorders   
hypertension  2/36 (5.56%) 
Gastrointestinal disorders   
Colitis  2/36 (5.56%) 
Constipation  4/36 (11.11%) 
Diarrhea  10/36 (27.78%) 
Distention/Bloating  2/36 (5.56%) 
Flatulence  2/36 (5.56%) 
Heartburn  3/36 (8.33%) 
Nausea  7/36 (19.44%) 
Phytobezoar  2/36 (5.56%) 
Vomiting  6/36 (16.67%) 
Abdomen pain  4/36 (11.11%) 
Stomach pain  3/36 (8.33%) 
General disorders   
Fatigue  4/36 (11.11%) 
Fever  2/36 (5.56%) 
Infections and infestations   
Upper airway infection  6/36 (16.67%) 
Investigations   
Weight loss  2/36 (5.56%) 
Metabolism and nutrition disorders   
Hyponatremia  2/36 (5.56%) 
Musculoskeletal and connective tissue disorders   
Back pain  3/36 (8.33%) 
Joint pain  3/36 (8.33%) 
Nervous system disorders   
Dizziness  6/36 (16.67%) 
Headache  6/36 (16.67%) 
Skin and subcutaneous tissue disorders   
Pruritus  2/36 (5.56%) 
Rash  3/36 (8.33%) 
Vascular disorders   
Phlebitis  2/36 (5.56%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sherry Chow
Organization: University of Arizona
Phone: 520-626-3358
EMail: schow@azcc.arizona.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01097304    
Other Study ID Numbers: NCI-2012-00450
NCI-2012-00450 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000669111
09-0141-03 ( Other Identifier: University of Arizona Health Sciences Center )
UAZ08-11-01 ( Other Identifier: DCP )
P50CA095060 ( U.S. NIH Grant/Contract )
N01CN35158 ( U.S. NIH Grant/Contract )
P30CA023074 ( U.S. NIH Grant/Contract )
First Submitted: March 31, 2010
First Posted: April 1, 2010
Results First Submitted: April 29, 2015
Results First Posted: May 15, 2015
Last Update Posted: December 19, 2017