NCT01765465|CompletedPhase 4ResultsDMC
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Sponsor study identifier
interventional
138
1 country
2
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Actual (reported)Study Completion
July 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 7, 2013
Actual (reported)January 10, 2013
Actual (reported)May 2014
Actual (reported)July 2014
Actual (reported)November 21, 2014
Actual (reported)the Number of the Participants Have Postoperative RUQ Pain
Right upper quadrant(RUQ) pain by European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ) C-30 No. 9, 19 at baseline and postoperative 3-month. The pain score of individuals at postoperative 3-month is calculated by EORTC QLQ C-30 manual. The pain score range is 0 to 100. Higher score means participants feel more pain(worse). If a participant's pain score is over 30, we define he/she has post operative RUQ pain. we use the number of the participants have post operative RUQ pain(score over 30) as the results.
postoperative 3-month
Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)
postoperative 3-month
Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)
postoperative 3-month
Laboratory Test Results of Postoperative 3-month(WBC Count)
postoperative 3-month
Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
DongGuk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773, South Korea
Chung-Ang University Hospital
Seoul, 156-755, South Korea
In Woong Han, M.D.
DongGuk University College of Medicine
138 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2013
First Posted
January 10, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
November 21, 2014
Results First Posted
November 21, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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