Back to resultsEffect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites (ECF)
Primary Purpose
Hyponatremia and Extracellular Fluid in Cirrhotic
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tolvaptan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyponatremia and Extracellular Fluid in Cirrhotic
Eligibility Criteria
Inclusion Criteria:
- Subjects aged ≥ 20 years
- Subjects who have been diagnosed with hyponatremia [serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction]
- Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
- Subjects who have diagnosed with cirrhosis.
- Subject or their legally acceptable representatives are able to provide informed consent/assent.
Exclusion Criteria:
- Subject who has ascites by other causes (Tbc, CHF, malignancy, or renal disease) acute severe hyponatemia : Serum Na level < 120 mmol/L and Doubt of symptom caused by hyponatremia and the case which should raise serum Na level urgently based on the investigator's judgment international normalized ratio (INR) >3.0 serum sodium ≥135 mmol/L serum potassium > 5.5 mmol/L Creatinine ≥ 2.0 mg/dL Hepatorenal syndrome defined as 'New International Ascites Club's diagnostic criteria' systolic arterial pressure of < 80 mmHg recent myocardial infarction (< 6 month) spontaneous bacterial peritonitis gastrointestinal bleed ( ≤7 days from randomization) ongoing hepatic encephalopathy of > grade1 known hepatocellular carcinoma intractable ascites
- Subject who requiring urgent intervention to raise serum sodium acutely
- Subject who are unable to sense or to respond appropriately to thirst
- Subject with hypovolemic hyponatremia
- Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
- Subject who are anuric as no benefit is expected
- Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subject who has fluid depletion
- Female subjects who are pregnant or lactating
- Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason
Sites / Locations
- Hallym Univ. Chuncheon Sacred Heart Hospital
- Soonchunhyang Univ. Bucheon Hospital
- Wonju Christian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tolvaptan
Placebo
Arm Description
Tablet, QD, 2 weeks
Tablet, QD, 2 weeks
Outcomes
Primary Outcome Measures
Serum Na
Secondary Outcome Measures
BCM (body composition monitoring)
body weight
A composite endpoint of ascites worsening
Serum Na normalization rate
Biochemistry
Total protein, Albumin, ALP, ALT, AST, r-GT, BUN, Creatinine, Glucose, Cl, K, Na, Ca, Total bilirubin, Uric acid), Hematology (WBC count, Hemoglobin, Hematocrit, Platelets, Serum osm, NT pro-BNP
ECG
Adverse event
Physical examination
HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae
Vital signs
Blood coagulation
PT, INR
Urinalysis
Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm
Full Information
NCT ID
NCT01552590
First Posted
February 21, 2012
Last Updated
February 17, 2022
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01552590
Brief Title
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
Acronym
ECF
Official Title
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and hyponatremia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia and Extracellular Fluid in Cirrhotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tolvaptan
Arm Type
Active Comparator
Arm Description
Tablet, QD, 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tablet, QD, 2 weeks
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Serum Na
Time Frame
2 weeks (Baseline, Day 14)
Secondary Outcome Measure Information:
Title
BCM (body composition monitoring)
Time Frame
7 days
Title
body weight
Time Frame
7 days
Title
A composite endpoint of ascites worsening
Time Frame
in case
Title
Serum Na normalization rate
Time Frame
14 days
Title
Biochemistry
Description
Total protein, Albumin, ALP, ALT, AST, r-GT, BUN, Creatinine, Glucose, Cl, K, Na, Ca, Total bilirubin, Uric acid), Hematology (WBC count, Hemoglobin, Hematocrit, Platelets, Serum osm, NT pro-BNP
Time Frame
7 days
Title
ECG
Time Frame
7 days
Title
Adverse event
Time Frame
Daily
Title
Physical examination
Description
HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae
Time Frame
7 days
Title
Vital signs
Time Frame
Daily
Title
Blood coagulation
Description
PT, INR
Time Frame
7 days
Title
Urinalysis
Description
Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects aged ≥ 20 years
Subjects who have been diagnosed with hyponatremia [serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction]
Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
Subjects who have diagnosed with cirrhosis.
Subject or their legally acceptable representatives are able to provide informed consent/assent.
Exclusion Criteria:
Subject who has ascites by other causes (Tbc, CHF, malignancy, or renal disease) acute severe hyponatemia : Serum Na level < 120 mmol/L and Doubt of symptom caused by hyponatremia and the case which should raise serum Na level urgently based on the investigator's judgment international normalized ratio (INR) >3.0 serum sodium ≥135 mmol/L serum potassium > 5.5 mmol/L Creatinine ≥ 2.0 mg/dL Hepatorenal syndrome defined as 'New International Ascites Club's diagnostic criteria' systolic arterial pressure of < 80 mmHg recent myocardial infarction (< 6 month) spontaneous bacterial peritonitis gastrointestinal bleed ( ≤7 days from randomization) ongoing hepatic encephalopathy of > grade1 known hepatocellular carcinoma intractable ascites
Subject who requiring urgent intervention to raise serum sodium acutely
Subject who are unable to sense or to respond appropriately to thirst
Subject with hypovolemic hyponatremia
Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
Subject who are anuric as no benefit is expected
Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subject who has fluid depletion
Female subjects who are pregnant or lactating
Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason
Facility Information:
Facility Name
Hallym Univ. Chuncheon Sacred Heart Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Soonchunhyang Univ. Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
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