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

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ClinicalTrials.gov Identifier: NCT01552590
Recruitment Status : Unknown
Verified January 2013 by Korea Otsuka Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 13, 2012
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Hyponatremia and Extracellular Fluid in Cirrhotic Drug: Tolvaptan Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
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
Study Start Date : April 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Tolvaptan, Tablet, QD, 2 weeks Drug: Tolvaptan
Placebo Comparator: Placebo, Tablet, QD, 2 weeks Drug: Placebo


Outcome Measures

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

Secondary Outcome Measures :
  1. BCM (body composition monitoring) [ Time Frame: 7 days ]
  2. body weight [ Time Frame: 7 days ]
  3. A composite endpoint of ascites worsening [ Time Frame: in case ]
  4. Serum Na normalization rate [ Time Frame: 14 days ]
  5. 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

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

  9. Vital signs [ Time Frame: Daily ]
  10. Blood coagulation [ Time Frame: 7 days ]
    PT, INR

  11. Urinalysis [ Time Frame: 7 days ]
    Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm


Eligibility Criteria

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 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