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

This study is currently recruiting participants.
Verified January 2013 by Korea Otsuka Pharmaceutical Co.,Ltd.
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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552590

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

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

No publications provided

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:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013