Phase II Pilot Study to Compare the Bioavailability of Bu... | NCT00004315

ID	Type	Description	Link
UCMC-CHMC-915717

Status Module

Record Verification Date

Apr 2002

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1995

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 1999

First Submission Date that Met QC Criteria

Oct 18, 1999

First Posted Date

Oct 19, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Name	Class
Children's Hospital Medical Center, Cincinnati	OTHER

Description Module

Brief Summary

OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease.

II. Compare the differences in pruritus, weight gain, and liver function for both treatments.

Detailed Description

PROTOCOL OUTLINE:

Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb). There is a 24-hour washout between each 4-week course of therapy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
ursodiol	Drug

Eligibility Module

Eligibility Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Chronic cholestatic liver disease

Cystic fibrosis-associated liver disease

--Prior/Concurrent Therapy--

Usual and customary diet maintained throughout study, e.g., medium-chain triglyceride oil

--Patient Characteristics--

Pulmonary: No serious respiratory deficiency

No acute illness

No inability to swallow

No fertile women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Balistreri	Children's Hospital Medical Center, Cincinnati	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Medical Center - Cincinnati		Cincinnati	Ohio	45229-3039	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D005767	Gastrointestinal Diseases
D002779	Cholestasis
D012140	Respiratory Tract Diseases
D030342	Genetic Diseases, Inborn
D035583	Rare Diseases

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007232	Infant, Newborn, Diseases
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003840	Deoxycholic Acid
D002793	Cholic Acids
D001647	Bile Acids and Salts
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D002757	Cholanes