E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing CECT imaging of the abdomen/pelvis as part of their routine medical care. |
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E.1.1.1 | Medical condition in easily understood language |
Patients referred to scans of their abdomen |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022086 |
E.1.2 | Term | Injection site pain |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013082 |
E.1.2 | Term | Discomfort |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003051 |
E.1.2 | Term | Application site pain |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing CECT imaging of the abdomen/pelvis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate and compare the impact of patient discomfort on image procedure and overall image quality and to evaluate and compare the overall safety profile in terms of occurrence of adverse events.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-The subject is over 18 years old. -Subjects are referred to undergo a CECT imaging of the abdomen/pelvis as part of their routine clinical care. -The subject has provided signed and dated informed consent.
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E.4 | Principal exclusion criteria |
-The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM. -The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period. -The subject is pregnant. -The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure. Note: Metformin must not be taken at least 24 hours prior to the study procedures, withheld for at least 48 hours post-procedure, and restarted only after the subjects renal function has been evaluated and it is deemed safe to resume metformin. -The subject manifests thyrotoxicosis or is on dialysis. -The subject was previously included in this study. -The subject has unstable clinical condition where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary safety endpoint is the comparison of the maximum intensity of patient discomfort between iodixanol 320 mg I/mL and iopamidol 370 mg I/mL as rated by the subjects within 10 minutes of intravenous contrast administration for their CECT imaging of the abdomen/pelvis. Patient discomfort includes sensations of coldness, heat or pain. The subject will be asked to separately rate the maximum intensity of the sensations of pain, warmth and coldness on a scale of 0-10 following the main bolus injection of CM and completion of the CT scan. The maximum intensity of patient discomfort score for each type will be converted into 4 categories: none = 0; mild= 1-3, Moderate = 4-7; severe = 8-10. The overall patient discomfort is defined as the maximum intensity of any individual discomfort score (i.e. pain, warmth or coldness).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
10 minutes after intravenous injection of contast agent |
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E.5.2 | Secondary end point(s) |
-To evaluate and compare the impact of image discomfort on image procedure and overall image quality -To evaluate and compare the overall safety profile in terms of occurrence of adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Adverse events are followed up for 24 hours |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Diagnostic trial Phase IV |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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From the 1st inclusion until last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |