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

This study has been completed.

Sponsored by: Eisai Limited
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00165620
  Purpose

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.


Condition Intervention Phase
Lesion
Drug: Iomeprole
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • Efficacy
  • Contrast enhancement effect in the early arterial phase
  • Safety
  • Warming sensation and vascular pain

Secondary Outcome Measures:
  • 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

Study Start Date:   November 2004

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both

Criteria

Inclusion Criteira:

  • Patients scheduled for a dynamic CT scan of the liver who have at least one hepatic lesion that has been confirmed by diagnostic imaging (ultrasonography, etc.) between 1 and 35 days before the start of the study treatment.
  • Patients who are 20 years or older at the time of obtaining informed consent.

Exclusion Criteria

  • Items that may affect the safety evaluation of E7337

    1. 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.
    2. 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).
    3. 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.
    4. Patients who continuously need to take analgesics between the morning of administration of E7337 and the completion of CT examinations.
    5. Patients who are currently participating in another clinical study.
    6. Patients who participated in another clinical study within 3 months prior to providing informed consent for this study.
    7. Patients weighing less than 55 kg (body weight at the time of obtaining informed consent).
  • General concerns relating to the safety of the subject.

    1. 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.)
    2. Patients with a history of hypersensitivity to iodine or iodinated contrast agents.
    3. Patients with serious thyroid disease (goiter, hyperthyroidism, etc.)
    4. 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)
    5. 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).
    6. 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).
    7. Patients with bronchial asthma
    8. Patients with acute pancreatitis
    9. Patients with macroglobulinemia
    10. Patients with multiple myeloma
    11. Patients with tetany
    12. Patients with pheochromocytoma or who are suspected to be pheochromocytoma
    13. Women of pregnant, childbearing potential, or lactating
    14. Patients with a history of hypersensitivity to drug(s)
    15. Patients with hypertension under medication
    16. Patients with diabetes under medication
    17. Patients with serious illness myasthenia
    18. Patients judged to be ineligible for study entry by an investigator or subinvestigator for any other reasons
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165620

Locations
Japan
      Kumamoto, Japan, :860-0811
Japan, Osaka
      Suita, Osaka, Japan, 565-0871

Sponsors and Collaborators
Eisai Limited

Investigators
Study Director:     Koichi Tazawa     Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center    
  More Information


ClinicalStudyResults.org ID number 1481  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   E7337-J081-141
First Received:   September 12, 2005
Last Updated:   September 25, 2008
ClinicalTrials.gov Identifier:   NCT00165620
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Signs and Symptoms
Liver Diseases

ClinicalTrials.gov processed this record on October 23, 2008




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