An open, randomized, controlled, single centre trial to evaluate CT image quality and diagnostic feasibility of Lumentin® 44, a new egg albumen based oral bowel filling agent, in comparison with diluted Omnipaque® and Movprep®, two commonly used agents in subjects referred for abdominal CT-examination.

ument AB0 个研究点目标入组 88 人开始时间: 2017年8月22日最近更新: 2019年11月25日

试验速览

暂无简介。

•1.Subjects of either gender at least 18 years at the time of signing the informed consent.
•2.Females must either present a negative pregnancy test or be surgically sterile (hysterectomy or tubal ligation) or postmenopausal (i.e. experienced 12 consecutive months without menstruation)
•3.Having a clinical indication for CT-examination of the abdomen
•4.Having fasted (drinking allowed) for at least four hours prior to the intake of the contrast agent
•5.Patients participating in concurrent oncology trial must either participate in the follow up phase of the clinical trial and currently receive no trial drug treatment since at least 6 weeks, or receive a reduced maintenance dose of the trial treatment
•6.Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any trial related activity is carried out.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 23
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 65

•1.IV administration of iodine is contraindicated
•2.Clinical suspicion, according to medical record, of fistula formation and/or leakage
•3.Having swallowing disorders preventing intake of the contrast agents
•4.Referral indication of small bowel disease(s)
•5.Known allergy to egg albumen
•6.Known sensitivity to any of the components of the investigational product or comparators
•7.Having known manifest thyrotoxicosis
•8.Having known phenylketonuria
•9.Having known Glucose-6-phosphatase deficiency
•10.Has taken any medication, absorbed through the small bowel, less than four hours before intake of the investigational product or comparators
•11.Being, in the opinion of the investigator, unlikely to comply with the clinical trial protocol
•12.Previously randomised to participate in this trial
•13.Participating in, or having participated in another, non-oncology clinical trial where the final trial treatment was given within the last 6 weeks
•14.Participating in an oncology clinical trial where the final full (i.e. non-maintenance) trial treatment was given within the last 6 weeks

发起方

ument AB