CirrhosisPhase 3NCT01114828
A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
A Phase 3 study testing OPC-41061 in people with Cirrhosis, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- OPC-41061
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2010to Dec 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients judged as having cirrhosis based on previous imaging diagnosis (Definition of cirrhosis includes patients with collateral circulation due to chronic hepatic impairment)
- Patients with ascites in whom the dose of existing diuretics cannot be increased due to risk of adverse drug reactions such as electrolyte abnormalities, or in whom sufficient therapeutic effect cannot be obtained with existing diuretics
- Patients who have been receiving oral combination therapy with a loop diuretic and an anti-aldosterone agent from at least 7 days prior to receipt of informed consent, with a dose combination of either loop diuretic equivalent to furosemide 40 mg/day or higher plus spironolactone 25 mg/day or higher, or loop diuretic equivalent to furosemide 20 mg/day or higher plus spironolactone 50 mg/day or higher
- Patients who are hospitalized or who can be hospitalized for the trial - Age 20 to 80 years inclusive
- Patients capable of giving informed consent
- Patients who, together with their partner, agree to use an appropriate method of contraception until 4 weeks after the final trial drug administration
Who cannot join
- Patients with any of the following complications or symptoms:
- Hepatic encephalopathy (hepatic coma of grade 2 or higher)
- Hepatocellular carcinoma with imaging-diagnosed vascular infiltration into trunk or primary branch of portal vein, inferior vena cava, or trunk of hepatic vein
- Endoscopic findings from screening examination or from within 30 days prior to screening examination indicating the need for new therapy for esophageal or gastric varices during the trial period
- Repeated hemorrhoidal bleeding due to rectal varicose veins within 30 days prior to informed consent
- Heart failure (New York Heart Association Class III or IV)
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- Anuria
- Impaired urination due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- Patients with a history of any of the following disorders:
- Cerebrovascular disorder within 30 days prior to informed consent
- Hypersensitivity or idiosyncratic reaction to benzazepine derivatives (such as mozavaptan hydrochloride or benazepril hydrochloride) "
- Morbidly obese patients with a body mass index (BMI: body weight (kg)/height (m)2) exceeding 35
- Patients with sitting systolic blood pressure lower than 90 mm Hg
- Patients with any of following abnormal clinical laboratory values at time of the screening examination: Hemoglobin lower than 8.0 g/dL, total bilirubin higher than 4.0 mg/dL, serum creatinine higher than 2.0 mg/dL, serum sodium higher than 147 mEq/L, or serum potassium higher than 5.5 mEq/L
- Patients who are unable to take oral medication
- Female patients who are pregnant, possibly pregnant, or breast-feeding, or who are planning to become pregnant
- Patients who have used albumin preparations (therapeutic agents for hypoalbuminemia) or blood products containing albumin from within 7 days prior to informed consent
- Patients who received any investigational drug other than OPC-41061 within 30 days prior to informed consent
- Patients who have previously received OPC-41061
- Any patient who, in the opinion of the principle investigator or subinvestigator, is inappropriate for participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Double-blind, Parallel-arm Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.
- Conditions
- Cirrhosis
- Being tested
- OPC-41061
- Keywords
- Cirrhosis, ascites, Tolvaptan, OPC-41061
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-41061Drug
Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
OPC-41061Drug
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 3.75 mg | Experimental | Once-daily oral administration of OPC-41061 Receives: Drug: OPC-41061 |
| 7.5 mg | Experimental | Once-daily oral administration of OPC-41061 Receives: Drug: OPC-41061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.
Measured: Bseline, Day 7 or at the discontined of treatment
Secondary outcomes (1)
Ascites Volume as Measured by CT
Change from baseline (day-1) for ascites volume as measured by CT at the end of treatment (LOCF) were calculated.
Measured: Baseline, Day 7 or at the discontinued of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuhisa Saito, Study director, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114828
- Sponsor's protocol ID
- 156-09-004
- Other IDs
- JapicCTI-101112
- Status last verified
- Jan 2014
- First submitted
- 29 Apr 2010
- Last updated
- 4 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Parallel-arm Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
- ClinicalTrials.gov ID
- NCT01114828
- Acronym / sponsor ID
- 156-09-004
- Conditions
- Cirrhosis
- Keywords
- Cirrhosis, ascites, Tolvaptan, OPC-41061
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Posted 31 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3.75 mg | Experimental | Drug: OPC-41061Once-daily oral administration of OPC-41061 |
| 7.5 mg | Experimental | Drug: OPC-41061Once-daily oral administration of OPC-41061 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients judged as having cirrhosis based on previous imaging diagnosis (Definition of cirrhosis includes patients with collateral circulation due to chronic hepatic impairment)
- Patients with ascites in whom the dose of existing diuretics cannot be increased due to risk of adverse drug reactions such as electrolyte abnormalities, or in whom sufficient therapeutic effect cannot be obtained with existing diuretics
- Patients who have been receiving oral combination therapy with a loop diuretic and an anti-aldosterone agent from at least 7 days prior to receipt of informed consent, with a dose combination of either loop diuretic equivalent to furosemide 40 mg/day or higher plus spironolactone 25 mg/day or higher, or loop diuretic equivalent to furosemide 20 mg/day or higher plus spironolactone 50 mg/day or higher
- Patients who are hospitalized or who can be hospitalized for the trial - Age 20 to 80 years inclusive
- Patients capable of giving informed consent
Key exclusion criteria (20 listed)
- Patients with any of the following complications or symptoms:
- Patients with a history of any of the following disorders:
- Morbidly obese patients with a body mass index (BMI: body weight (kg)/height (m)2) exceeding 35
- Patients with sitting systolic blood pressure lower than 90 mm Hg
- Patients with any of following abnormal clinical laboratory values at time of the screening examination: Hemoglobin lower than 8.0 g/dL, total bilirubin higher than 4.0 mg/dL, serum creatinine higher than 2.0 mg/dL, serum sodium higher than 147 mEq/L, or serum potassium higher than 5.5 mEq/L
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 |
|---|---|---|
| OPC-41061Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days | Drug | 3.75 mg |
| OPC-41061Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days | Drug | 7.5 mg |
Primary outcome
Body Weight
Time frame: Bseline, Day 7 or at the discontined of treatment
Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.
1 secondary outcome
Ascites Volume as Measured by CT
Time frame: Baseline, Day 7 or at the discontinued of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katsuhisa Saito study director
Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OPC-41061 in people with Cirrhosis, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
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 6 inclusion and 20 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: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Weight (time frame: Bseline, Day 7 or at the discontined of treatment). 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 2014.