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

NCT ID: NCT01552590

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-04-30

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

Conditions

Hyponatremia and Extracellular Fluid in Cirrhotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tolvaptan

Tablet, QD, 2 weeks

Group Type: ACTIVE_COMPARATOR

Tolvaptan

Intervention Type: DRUG

Placebo

Tablet, QD, 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Tolvaptan

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hallym Univ. Chuncheon Sacred Heart Hospital

Bucheon-si, , South Korea

Soonchunhyang Univ. Bucheon Hospital

Bucheon-si, , South Korea

Wonju Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

Other Identifiers

156-KOB-1101i

Identifier Type: -

Identifier Source: org_study_id