Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites (ECF)

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Hyponatremia and Extracellular Fluid in Cirrhotic	Drug: Tolvaptan; Drug: Placebo	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	74 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
Study Start Date :	April 2012
Estimated Primary Completion Date :	January 2013
Estimated Study Completion Date :	January 2013

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Tolvaptan, Tablet, QD, 2 weeks	Drug: Tolvaptan
Placebo Comparator: Placebo, Tablet, QD, 2 weeks	Drug: Placebo

Outcome Measures

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Primary Outcome Measures :

1. Serum Na [ Time Frame: 2 weeks (Baseline, Day 14) ]

Secondary Outcome Measures :

1. BCM (body composition monitoring) [ Time Frame: 7 days ]
2. body weight [ Time Frame: 7 days ]
3. A composite endpoint of ascites worsening [ Time Frame: in case ]
4. Serum Na normalization rate [ Time Frame: 14 days ]
5. Biochemistry [ Time Frame: 7 days ]
   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
6. ECG [ Time Frame: 7 days ]
7. Adverse event [ Time Frame: Daily ]
8. Physical examination [ Time Frame: 7 days ]
   HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae
9. Vital signs [ Time Frame: Daily ]
10. Blood coagulation [ Time Frame: 7 days ]
    PT, INR
11. Urinalysis [ Time Frame: 7 days ]
    Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Subjects aged ≥ 20 years
2. 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]
3. Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
4. Subjects who have diagnosed with cirrhosis.
5. Subject or their legally acceptable representatives are able to provide informed consent/assent.

Exclusion Criteria:

1. 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
2. Subject who requiring urgent intervention to raise serum sodium acutely
3. Subject who are unable to sense or to respond appropriately to thirst
4. Subject with hypovolemic hyponatremia
5. Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
6. Subject who are anuric as no benefit is expected
7. Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8. Subject who has fluid depletion
9. Female subjects who are pregnant or lactating
10. Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: YoungJin Choi	+82232879255	youngjin@otsuka.co.kr

Locations

Korea, Republic of
Hallym Univ. Chuncheon Sacred Heart Hospital	Recruiting
Bucheon, Korea, Republic of
Contact: KiTae Suk, Assistant professor
Principal Investigator: KiTae Suk, Assistant professor
Soonchunhyang Univ. Bucheon Hospital	Recruiting
Bucheon, Korea, Republic of
Contact: YoungSeok Kim, Associate professor
Principal Investigator: YoungSeok Kim, Associate professor
Wonju Christian Hospital	Recruiting
Wonju, Korea, Republic of
Contact: SoonKoo Baik, Professor
Principal Investigator: SoonKoo Baik, Professor

Sponsors and Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01552590 History of Changes
Other Study ID Numbers:	156-KOB-1101i
First Posted:	March 13, 2012
Last Update Posted:	January 4, 2013
Last Verified:	January 2013

Additional relevant MeSH terms:

Ascites; Hyponatremia; Pathologic Processes; Water-Electrolyte Imbalance; Metabolic Diseases	Tolvaptan; Antidiuretic Hormone Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Physiological Effects of Drugs