- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01097304
Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia
Clinical Study of Ursodeoxycholic Acid in Barrett's Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the ability of UDCA (ursodiol) treatment to reverse oxidative deoxyribonucleic acid (DNA) damage in the esophageal epithelium of subjects with Barrett's esophagus.
SECONDARY OBJECTIVES:
I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell proliferation in Barrett's epithelium.
OUTLINE:
Patients receive ursodiol orally (PO) twice daily (BID) for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 2 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona Health Sciences Center
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Tucson, Arizona, United States, 85723
- Southern Arizona Veterans Affairs Health Center
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Tucson, Arizona, United States, 85724-5024
- Arizona Cancer Center-North Campus
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Barrett's esophagus with histologically-confirmed intestinal metaplasia anywhere in the tubular esophagus either with >= 2 cm of involvement or with a minimum circumferential Barrett's esophagus (BE) length of 1 cm
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin =< 2.0 mg/dL
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2 X institutional upper limit of normal (ULN)
- Creatinine =< 1X ULN
- Women of child-bearing potential (i.e., not surgically sterile or less than one year since last menstrual period) agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women of childbearing potential must have a negative urine pregnancy test within 14 days prior to study agent administration; male subjects must agree to use adequate contraception (barrier method, abstinence, subject has had vasectomy or partner is using effective birth control or is postmenopausal)
- Ability to understand and the willingness to sign a written informed consent document
- Agree to refrain from any non-steroidal anti-inflammatory drug (NSAID) with the exception of low-dose aspirin (81 mg once daily [QD]) during the entire study period
- Agree not to take aluminum-containing antacids and anion exchange resins such as cholestyramine, colestimide or colestipol within 2 hours of taking UDCA
Exclusion Criteria:
- Barrett's esophagus with high grade dysplasia or carcinoma at enrollment
- Medical conditions which would make completing endoscopies or completing the trial difficult including but not limited to previous transient ischemic attacks or cerebral vascular disease, severe respiratory disease, severe ischemic heart disease or myocardial infarction in the previous 6 months, inflammatory bowel disease
- Participants may not be receiving any other investigational agents within 1 month of study enrollment
- Have used NSAID for more than 5 days per month within 1 month of enrollment except low dose aspirin (81 mg QD)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to UDCA
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and breastfeeding women are excluded from this study; breastfeeding should be discontinued during treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Have had major upper gastrointestinal (GI) surgeries within 6 months of enrollment including, but not limited to, fundoplication, bariatric surgery, cholecystectomy
- Erosive esophagitis detected at the baseline endoscopy
- Participants who need concurrent chemotherapy, radiotherapy, or cancer-related hormonal or immunotherapy during the time of study
- Participants who have had chemotherapy, radiotherapy, or cancer-related hormonal or immunotherapy within 18 months of the baseline visit
- Current or planned use of anticoagulant drugs including, but not limited to, warfarin, heparin, low molecular weight heparin, Plavix, or Aggrenox
- Use of cyclosporine during the time of study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (ursodiol)
Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining
Time Frame: Baseline to 6 months
|
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.
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
|
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
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
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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 will be analyzed using paired t-tests.
Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.
|
Baseline and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bhaskar Banerjee, University of Arizona Health Sciences Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Precancerous Conditions
- Esophageal Neoplasms
- Barrett Esophagus
- Gastrointestinal Agents
- Cholagogues and Choleretics
- Ursodeoxycholic Acid
Other Study ID Numbers
- NCI-2012-00450 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA023074 (U.S. NIH Grant/Contract)
- 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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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