None. Lumentin 44 is a contrast agent and the contrast properties will be investigated in this trial. Patients referred to computerised tomography of the abdomen will be included in the trial. Neither their medical condition nor disease will be investigated. MedDRA version: 20.1 Level: LLT Classification code 10011603 Term: CT scan System Organ Class: 100000004848
Conditions
Interventions
Product Name: Lumentin 44
Product Code: L 44
Pharmaceutical Form: Oral liquid
INN or Proposed INN: Egg Albumen Powder
Other descriptive name: EGG WHITE PROTEIN
Concentration unit: g/l gram(s)/litre
Co
Sponsors
Lument AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To describe and compare the ability of Lumentin® 44 to fill the bowel as compared to Movprep® and diluted Omnipaque®. • To describe and assess how Lumentin® 44 influences reading of the abdominal CT-examination as compared to Movprep® and diluted Omnipaque® with respect to: o Diagnostics with particular regard to parenchymal organs, lymphatic system and tissue compartments beyond the gastrointestinal tract • To investigate signs of degradation of Lumentin® 44 in terms of o Coalesence o Syneresis or drainage • Describe and compare the ability to eat/drink for each of three contrast agents with respect to: o Taste o Smell o Consistency o Ability to swallow o Fullness • To evaluate safety and tolerability after oral administration of each of three contrast agents ;Primary end point(s): The mean difference in contrast density in HU, expressed as the mean of 9 measurements of contrast density differences between bowel lumen and wall (mucosal lining) performed in the 5 sub-segments of the small bowel.;Timepoint(s) of evaluation of this end point: Day 1;Main Objective: To compare the mean difference incontrast density shown on abdominal CT-images when using the contrast agent Lumentin® 44, with abdominal CT-images using diluted Omnipaque® and with abdominal CT-images using Movprep® | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Bowel filling properties (extension and distension) on Abd-CT in each of 5 sub-segments of the small bowel • Degradation (presence of bubbles and signs of sedimentation) on Abd-CT in each of 5 sub-segments of the small bowel • Diagnostic ability on Abd-CT of the parenchyma, lymphatic system and tissue compartments beyond the gastrointestinal tract. • Subject assessments of taste, smell, consistency, ability to swallow and fullness after swallowing the contrast agent • Safety Parameters ;Timepoint(s) of evaluation of this end point: All secondary end points will be evaluated on day 1. Safety Parameters will be evaluated on day 1 and between 12 to 48 hours post day 1 | — |
Countries
Sweden
Contacts
Public ContactOlof Böök
Lument AB
Outcome results
None listed