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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2013 by Korea Otsuka Pharmaceutical Co., Ltd..
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Korea Otsuka Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01552590

First received: February 21, 2012

Last updated: January 3, 2013

Last verified: January 2013

History of Changes

Purpose

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	Intervention	Phase
Hyponatremia and Extracellular Fluid in Cirrhotic	Drug: Tolvaptan Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites

Resource links provided by NLM:

Drug Information available for: Tolvaptan

U.S. FDA Resources

Further study details as provided by Korea Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Serum Na [ Time Frame: 2 weeks (Baseline, Day 14) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BCM (body composition monitoring) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
body weight [ Time Frame: 7 days ] [ Designated as safety issue: No ]
A composite endpoint of ascites worsening [ Time Frame: in case ] [ Designated as safety issue: No ]
Serum Na normalization rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Biochemistry [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Adverse event [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae
Vital signs [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Blood coagulation [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
PT, INR
Urinalysis [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm


Estimated Enrollment:	74
Study Start Date:	April 2012
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Tolvaptan, Tablet, QD, 2 weeks	Drug: Tolvaptan
Placebo Comparator: Placebo, Tablet, QD, 2 weeks	Drug: Placebo

Eligibility


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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552590

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


Responsible Party:	Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01552590 History of Changes
Other Study ID Numbers:	156-KOB-1101i
Study First Received:	February 21, 2012
Last Updated:	January 3, 2013
Health Authority:	Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016

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