A Randomized, Open, Parallel, Optimal Injection Rate-Finding Study for E7337 in Dynamic CT of the Liver in Patients With Liver Disease

NCT00165620 | Completed Phase 2

• 1 other identifier: E7337-J081-141
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

To establish the optimum injection rate for E7337 (Iomeron 350) in dynamic CT in patients who have hepatic lesions.The primary endpoint for efficacy is the contrast enhancement effect in the early arterial phase, and the primary safety endpoints are warming sensation and vascular pain.

Conditions

Lesion

Outcome Measures

Primary Outcomes (4)

• Efficacy

• Contrast enhancement effect in the early arterial phase

• Safety

• Warming sensation and vascular pain

Secondary Outcomes (4)

• Efficacy

• Contrast enhancement effect in the portal phase

• Safety and arterial, portal venous and liver parenchymal CT values (HU)

• Symptoms and signs（excluding warming sensation and vascular pain ）, and life signs (blood pressure, pulse), etc., and laboratory tests (hematology, serum chemistry) conducted before and after administration of the investigational agent

Interventions

Iomeprole DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Items that may affect the safety evaluation of E7337
• Patients who have undergone or are scheduled to undergo an examination using another contrast agent between 7 days before administration of E7337 and the time of follow-up examinations on Day 8 after administration.
• Patients for whom follow-ups seem to be difficult to conduct until the time of examination on Day 8 (i.e. when it may fail to evaluate delayed adverse drug reactions).
• Patients who have undergone or are scheduled to undergo surgical treatment or a therapy such as percutaneous ethanol injection therapy, percutaneous microwave coagulation therapy, radiofrequency ablation, or transcatheter arterial embolization, etc., from the time diagnostic imaging such as abdominal ultrasonography is performed up until follow-up examinations are conducted on Day 8 after administration.
• Patients who continuously need to take analgesics between the morning of administration of E7337 and the completion of CT examinations.
• Patients who are currently participating in another clinical study.
• Patients who participated in another clinical study within 3 months prior to providing informed consent for this study.
• Patients weighing less than 55 kg (body weight at the time of obtaining informed consent).
• General concerns relating to the safety of the subject.
• Patients in the acute stage with clinically unstable symptoms, or in a life-threatening condition (when it is expected that emergency treatment is required between the time of registration and the end of the follow-up period, or when the patient is not expected to survive for 3 months following administration of E7337, etc.)
• Patients with a history of hypersensitivity to iodine or iodinated contrast agents.
• Patients with serious thyroid disease (goiter, hyperthyroidism, etc.)
• Patients with serious cardiopathy (NYHA functional class IV heart failure as described in Appendix 5, shock, cyanosis, peripheral circulatory insufficiency, ventricular tachycardia, ventricular fibrillation, or complete atrioventricular block)
• Patients with serious hepatopathy (symptoms of liver failure \[fulminant hepatitis\] such as a disturbance of consciousness corresponding to grade 3 in the Criteria for Grading Adverse Drug Reactions of Medicinal Products in Appendix 5).
• Patients with moderate or serious nephropathy (acute or chronic renal failure, hydronephrosis, nephrotic syndrome, or uremia with serum creatinine levels of 2.0 mg/dL or above, corresponding to grade 2 or above in the Criteria for Grading Adverse Drug Reactions of Medicinal Products in Appendix 5).

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (2)

Unknown Facility

Kumamoto, Kumamoto, :860-0811, Japan

Location

Unknown Facility

Suita, Osaka, 565-0871, Japan

Location

Study Officials

• Koichi Tazawa

  Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: November 1, 2004
• Primary Completion: April 1, 2005
• Last Updated: January 29, 2010

Record last verified: 2010-01

Locations

JP (2)