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COMPLETEDPHASE3

A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema

NCT01050530•Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and the change in body weight from baseline at the time of the final administration will be compared between the two groups.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

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
•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
+10 more criteria

Locations (8)

Chubu Region, Japan

Chugoku Region, Japan

Hokkaido Region, Japan

Kanto Region, Japan

Kinki Region, Japan

Kyushu Region, Japan

Shikoku Region, Japan

Tohoku Region, Japan

Key Dates

Start Date

December 1, 2009

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2012

Last Updated

March 4, 2014

Enrollment

162

ACTUAL participants

Conditions

Cirrhosis

Interventions

OPC-41061

DRUG

Placebo

DRUG

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

NCT05597488

Cirrhosis Portal

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RECRUITINGNA

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

NCT06932783

Cirrhosis

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RECRUITING

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema

Inclusion Criteria

Exclusion Criteria

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Mechanism of TIPS to Improve Sarcopenia

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation