NCT00634140

Brief Summary

Ezetimibe is a drug which inhibits the absorption of both dietary and biliary cholesterol in the small intestine. Ezetimibe has been approved for use in humans to lower serum cholesterol. The primary aim of this study is to determine if ezetimibe normalizes resting and residual volume in patients with chronic acalculous cholecystitis.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

Same day

First QC Date

March 3, 2008

Last Update Submit

March 27, 2015

Conditions

Chronic Acalculous Cholecystitis

Keywords

gallbladderezetimibe for 4 to 6 weeks prior to gallbladder removal

Outcome Measures

Primary Outcomes (1)

  • Normalization of resting gallbladder volume in patients with chronic acalculous cholecystitis

    Approximately 6 weeks after treatment

Study Arms (2)

1

EXPERIMENTAL

ezetimibe

Drug: ezetimibe

2

PLACEBO COMPARATOR

placebo for 4-6 weeks

Drug: Placebo

Interventions

ezetimibeDRUG

ezetimibe 10 mg daily for 4 to 6 weeks

Also known as: Zetia
1
PlaceboDRUG

placebo for 4-6 weeks

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with typical biliary pain and ejection fraction \<30% on a HIDA scan.
  • Must be \> 18 years of age.

You may not qualify if:

  • Subjects with gallstones seen on HIDA.
  • Subjects on statin medication
  • Subjects with known allergies to ezetimibe.
  • Subjects who are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Ezetimibe

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Henry A. Pitt, MD

    Indiana University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2008

First Posted

March 12, 2008

Study Start

August 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

US(1)