Hyponatremia and Extracellular Fluid in CirrhoticPhase 4ECFNCT01552590
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
A Phase 4 study testing Tolvaptan in people with Hyponatremia and Extracellular Fluid in Cirrhotic, run by Korea Otsuka Pharmaceutical Co., Ltd. at 3 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyponatremia and Extracellular Fluid in Cirrhotic
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Apr 2012to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
- Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Hallym Univ. Chuncheon Sacred Heart Hospital
Bucheon-si
Soonchunhyang Univ. Bucheon Hospital
Bucheon-si
Wonju Christian Hospital
Wŏnju
About this study
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
- Being tested
- Tolvaptan, Placebo
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan | Active comparator | Tablet, QD, 2 weeks Receives: Drug: Tolvaptan |
| Placebo | Placebo comparator | Tablet, QD, 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Na
Measured: 2 weeks (Baseline, Day 14)
Secondary outcomes (11)
BCM (body composition monitoring)
Measured: 7 days
body weight
Measured: 7 days
A composite endpoint of ascites worsening
Measured: in case
Serum Na normalization rate
Measured: 14 days
Biochemistry
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
Measured: 7 days
ECG
Measured: 7 days
Adverse event
Measured: Daily
Physical examination
HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae
Measured: 7 days
Vital signs
Measured: Daily
Blood coagulation
PT, INR
Measured: 7 days
Urinalysis
Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyponatremia and Extracellular Fluid in CirrhoticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552590
- Sponsor's protocol ID
- 156-KOB-1101i
- Acronym
- ECF
- Status last verified
- Oct 2014
- First submitted
- 21 Feb 2012
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
- ClinicalTrials.gov ID
- NCT01552590
- Acronym / sponsor ID
- ECF / 156-KOB-1101i
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolvaptan | Active comparator | Drug: TolvaptanTablet, QD, 2 weeks |
| Placebo | Placebo comparator | Drug: PlaceboTablet, QD, 2 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolvaptan | Drug | Tolvaptan |
| Placebo | Drug | Placebo |
Primary outcome
Serum Na
Time frame: 2 weeks (Baseline, Day 14)
11 secondary outcomes
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
ECG
Time frame: 7 days
Adverse event
Time frame: Daily
Physical examination
Time frame: 7 days
Vital signs
Time frame: Daily
Blood coagulation
Time frame: 7 days
Urinalysis
Time frame: 7 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tolvaptan in people with Hyponatremia and Extracellular Fluid in Cirrhotic, run by Korea Otsuka Pharmaceutical Co., Ltd. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Na (time frame: 2 weeks (Baseline, Day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.