This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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 (Participant)
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:


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

Primary Outcome Measures:
  • Serum Na [ Time Frame: 2 weeks (Baseline, Day 14) ]

Secondary Outcome Measures:
  • BCM (body composition monitoring) [ Time Frame: 7 days ]
  • body weight [ Time Frame: 7 days ]
  • A composite endpoint of ascites worsening [ Time Frame: in case ]
  • Serum Na normalization rate [ Time Frame: 14 days ]
  • 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

  • ECG [ Time Frame: 7 days ]
  • Adverse event [ Time Frame: Daily ]
  • Physical examination [ Time Frame: 7 days ]
    HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae

  • Vital signs [ Time Frame: Daily ]
  • Blood coagulation [ Time Frame: 7 days ]
    PT, INR

  • Urinalysis [ Time Frame: 7 days ]
    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)
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
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

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 August 21, 2017