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Clinical Study of Ursodeoxycholic Acid in Barrett's Patients

Phase 2
18 Years
Open (Enrolling)
Barrett Esophagus, Esophageal Cancer

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Trial Information

Clinical Study of Ursodeoxycholic Acid in Barrett's Patients


I. To evaluate the ability of ursodeoxycholic acid (ursodiol, UDCA) treatment to reverse
oxidative deoxyribonucleic acid (DNA) damage in the esophageal epithelium of subjects with
Barrett's esophagus (BE).


I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell
proliferation in Barrett's epithelium.


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.

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 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 glutamic pyruvic transaminase [SGPT]) =<
2X 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Reversal of oxidative DNA damage as assessed by changes in 8OHdG immunostaining

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Bhaskar Banerjee

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona Health Sciences Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

Related Keywords:

  • Barrett Esophagus
  • Esophageal Cancer
  • Barrett Esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms



University of North Carolina Chapel Hill, North Carolina  27599
University of Arizona Health Sciences Center Tucson, Arizona  85724
Southern Arizona Veterans Affairs Health Center Tucson, Arizona  85723