E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients that are referred to undergo a peripheral arterigraphy as part of their routine clinical care. |
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E.1.1.1 | Medical condition in easily understood language |
Investigation of patient referred to have an investigation of their blood vessels |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058049 |
E.1.2 | Term | Administration 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 | 14.1 |
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 | 14.1 |
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.1.3 | 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 an iso-osmolar contrast medium (IOCM), iodixanol 320 mg I/mL, and a low osmolar contrast medium (LOCM), iopamidol 370 mg I/mL, in patients undergoing peripheral arteriography.
The patient discomfort is defined as a sensation of coldness or, heat and injection-associated pain experienced by the patient that is temporally associated with the injection/infusion of a contrast medium.
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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.
•To evaluate and compare the overall safety profile in terms of occurrence of adverse events within 24 hours following the contrast media CM administration.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1)The subject is over 18 years old.
(2)Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.
(3)The subject has provided signed and dated informed consent.
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E.4 | Principal exclusion criteria |
(1) The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
(2) The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within 24 hours follow-up period.
(3) The subject is pregnant or lactating.
(4) 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.
(5)The subject manifests thyrotoxicosis or is on dialysis.
(6)The subject was previously included in this study.
(7)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 as rated by the subjects during the overall peripheral arteriography following administration of iodixanol 320 mg I/mL versus iopamidol 370 mg I/mL.
The intensity of the sensation of coldness or heat and injection associated pain after each injection will be rated separately by the subject using a scale of 0-10.
Patient discomfort (i.e. pain, heat or coldness) score/category:
–Subjects rate maximum intensity of the sensations of coldness, heat and pain on a scale of 0 -10.
–Intensity categories: none = 0; mild= 1-3, Moderate = 4-7; severe = 8-10.
–The overall patient discomfort is defined as the maximum of the individual discomfort ratings (i.e., pain, warmth or coldness).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary end point will be evaluted up to 10 minutes after injection. Other safety assessments up til 24 hours after injection. |
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E.5.2 | Secondary end point(s) |
Frequency of subjects with patient discomfort following intra-arterial administration of either iodixanol 320 mg I/mL or iopamidol 370 mg I/mL for peripheral arteriography. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The primary end point will be evaluted up to 10 minutes after injection. Other safety assessments up til 24 hours after injection. |
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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 |
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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 | Yes |
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 | 6 |
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 |
Germany |
Spain |
United Kingdom |
United States |
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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 |