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Trial record 23 of 1390 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Postcholecystectomy Syndrome
Interventions Drug: Rowachol
Drug: Placebo
Enrollment 138
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rowachol Placebo
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Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months

Rowachol

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

Placebo

Period Title: Overall Study
Started 71 67
Completed 64 63
Not Completed 7 4
Arm/Group Title Rowachol Placebo Total
Hide Arm/Group Description

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

Rowachol

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

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 71 67 138
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 67 participants 138 participants
51.48  (15.56) 47.99  (13.81) 49.78  (14.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 67 participants 138 participants
Female
45
  63.4%
34
  50.7%
79
  57.2%
Male
26
  36.6%
33
  49.3%
59
  42.8%
1.Primary Outcome
Title the Number of the Participants Have Postoperative RUQ Pain
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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.

Time Frame postoperative 3-month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rowachol Placebo
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Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months

Rowachol

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

Placebo

Overall Number of Participants Analyzed 64 63
Measure Type: Number
Unit of Measure: number of participants
3 9
2.Secondary Outcome
Title Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)
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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.

Time Frame postoperative 3-month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rowachol Placebo
Hide Arm/Group Description:

Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month

Rowachol

Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month

Placebo

Overall Number of Participants Analyzed 64 63
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total bilirubin 0.7  (0.5) 0.6  (0.2)
Direct bilirubin 0.3  (0.3) 0.2  (0.2)
3.Secondary Outcome
Title Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)
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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.

Time Frame postoperative 3-month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rowachol Placebo
Hide Arm/Group Description:

Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month

Rowachol

Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month

Placebo

Overall Number of Participants Analyzed 64 63
Mean (Standard Deviation)
Unit of Measure: IU/dL
Alkaline phosphatase 242.8  (449.8) 209.6  (145.5)
Aspartate aminotransferase 105.1  (60.5) 50.8  (41.2)
Alanine aminotransferase 44.3  (43.8) 56.1  (49.1)
4.Secondary Outcome
Title Laboratory Test Results of Postoperative 3-month(WBC Count)
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laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group.

each result is mean values.

Time Frame postoperative 3-month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rowachol Placebo
Hide Arm/Group Description:

Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month

Rowachol

Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month

Placebo

Overall Number of Participants Analyzed 64 63
Mean (Standard Deviation)
Unit of Measure: cells (10^6/µl)
6.8  (2.1) 7.2  (2.4)
Time Frame postoperative 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rowachol Placebo
Hide Arm/Group Description

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

Rowachol

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

Placebo

All-Cause Mortality
Rowachol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rowachol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      0/63 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rowachol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      1/63 (1.59%)    
Hepatobiliary disorders     
Post operative minor bile leak *  0/64 (0.00%)  0 1/63 (1.59%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. In Woong Han
Organization: DongGuk University Ilsan Hospital
Responsible Party: In Woong Han, DongGuk University
ClinicalTrials.gov Identifier: NCT01765465     History of Changes
Other Study ID Numbers: S-2012-E0816-00001
First Submitted: January 7, 2013
First Posted: January 10, 2013
Results First Submitted: October 15, 2014
Results First Posted: November 21, 2014
Last Update Posted: November 21, 2014