- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01114828
A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
January 30, 2014 updated by: Otsuka Pharmaceutical Co., Ltd.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, et al., Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 3.75 mg
Once-daily oral administration of OPC-41061
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Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
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Experimental: 7.5 mg
Once-daily oral administration of OPC-41061
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Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight
Time Frame: Bseline, Day 7 or at the discontined of treatment
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Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.
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Bseline, Day 7 or at the discontined of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ascites Volume as Measured by CT
Time Frame: Baseline, Day 7 or at the discontinued of treatment
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Change from baseline (day-1) for ascites volume as measured by CT at the end of treatment (LOCF) were calculated.
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Baseline, Day 7 or at the discontinued of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Katsuhisa Saito, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 29, 2010
First Submitted That Met QC Criteria
April 30, 2010
First Posted (Estimate)
May 3, 2010
Study Record Updates
Last Update Posted (Estimate)
March 4, 2014
Last Update Submitted That Met QC Criteria
January 30, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 156-09-004
- JapicCTI-101112 (Other Identifier: JAPIC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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