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Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

NCT ID: NCT01765465

Last Updated: 2014-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-07-31

Brief Summary

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Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually manifested by the presence of abdominal symptoms following gallbladder removal. The pathogenesis of PCS has not been identified; therefore there is no consensus of medical treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients with cholesterol gallstones, and to promote biliary lipid secretion.

The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS and symptoms change after laparoscopic cholecystectomy

Detailed Description

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Conditions

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Postcholecystectomy Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Rowachol

Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months

Group Type EXPERIMENTAL

Rowachol

Intervention Type DRUG

Placebo

Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Rowachol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with pathologic diseases scheduled for laparoscopic cholecystectomy

Exclusion Criteria

* Current immunosuppressive therapy
* Chemotherapy within 4 weeks before operation
* Radiotherapy completed longer than 4 weeks before operation
* Inability to follow the instructions given by the investigator
* Severe psychiatric or neurologic diseases
* Drug- and/or alcohol-abuse according to local standards
* Participation in another intervention-trial with interference of a primary or secondary endpoint of this study
* Lack of compliance
* Lack of informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmbio Korea Co., Ltd.

INDUSTRY

Sponsor Role collaborator

DongGuk University

OTHER

Sponsor Role lead

Responsible Party

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In Woong Han

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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In Woong Han, M.D.

Role: PRINCIPAL_INVESTIGATOR

DongGuk University College of Medicine

Locations

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DongGuk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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S-2012-E0816-00001

Identifier Type: -

Identifier Source: org_study_id