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

NCT01552590 | Terminated Phase 4

• 1 other identifier: 156-KOB-1101i
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Serum Na

  2 weeks (Baseline, Day 14)

Secondary Outcomes (11)

• BCM (body composition monitoring)

  7 days

• body weight

  7 days

• A composite endpoint of ascites worsening

  in case

• Serum Na normalization rate

  14 days

• Biochemistry

  7 days

Study Arms (2)

Tolvaptan

ACTIVE COMPARATOR

Tablet, QD, 2 weeks

Drug: Tolvaptan

Placebo

PLACEBO COMPARATOR

Tablet, QD, 2 weeks

Drug: Placebo

Interventions

Tolvaptan DRUG

Tolvaptan

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (3)

Hallym Univ. Chuncheon Sacred Heart Hospital

Bucheon-si, South Korea

Location

Soonchunhyang Univ. Bucheon Hospital

Bucheon-si, South Korea

Location

Wonju Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Hyponatremia

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 13, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 4, 2022

Record last verified: 2014-10

Locations

KR (3)