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Trial record 23 of 1425 for:    bilirubin AND alanine

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

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ClinicalTrials.gov Identifier: NCT01765465
Recruitment Status : Completed
First Posted : January 10, 2013
Results First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
In Woong Han, DongGuk University

Tracking Information
First Submitted Date  ICMJE January 7, 2013
First Posted Date  ICMJE January 10, 2013
Results First Submitted Date  ICMJE October 15, 2014
Results First Posted Date  ICMJE November 21, 2014
Last Update Posted Date November 21, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2014)
the Number of the Participants Have Postoperative RUQ Pain [ Time Frame: postoperative 3-month ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2013)
Right upper quadrant(RUQ) pain score [ Time Frame: baseline and postoperative 3 months after ]
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 months after. The difference of Pain score from 3months to baseline will be calculated by EORTC QLQ C-30 manual.
Change History Complete list of historical versions of study NCT01765465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2014)
  • Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) [ Time Frame: postoperative 3-month ]
    laboratory test results(liver function test such as total bilirubin, direct bilirubin) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values.
  • Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) [ Time Frame: postoperative 3-month ]
    laboratory test results(liver function test such as Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values.
  • Laboratory Test Results of Postoperative 3-month(WBC Count) [ Time Frame: postoperative 3-month ]
    laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2013)
Changing pattern of liver function test [ Time Frame: baseline and postoperative 3 months after ]
3 months minus baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Rowachol on Prevention of Postcholecystectomy Syndrome
Official Title  ICMJE Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy
Brief Summary

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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Postcholecystectomy Syndrome
Intervention  ICMJE
  • Drug: Rowachol
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Rowachol
    Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
    Intervention: Drug: Rowachol
  • Placebo Comparator: Placebo
    Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2013)
138
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01765465
Other Study ID Numbers  ICMJE S-2012-E0816-00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party In Woong Han, DongGuk University
Study Sponsor  ICMJE DongGuk University
Collaborators  ICMJE Pharmbio Korea Co., Ltd.
Investigators  ICMJE
Principal Investigator: In Woong Han, M.D. DongGuk University College of Medicine
PRS Account DongGuk University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP