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This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenetix | Experimental | The patient receive one injection of Xenetix 300 (300 mg of iodine/ml) |
|
| Visipaque | Active Comparator | The patient receive one injection of Visipaque 270 (270 mg of iodine/ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenetix | Drug | 300 mg of iodine/ml |
| |
| Visipaque |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine Clearance | The variation of creatinine clearance before and after the product injection was measured | between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Dubourdieu, PhD | Guerbet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Charles Nicolle | Rouen | 76031 | France |
Any patient having a creatinine clearance < 60ml/min/1.73m² at time of baseline blood sample and/or positive beta HCG (Human Chorionic Gonadotropin) within 48h before contrast medium administration was considered as immediate withdrawal from trial
First patient first visit = 30/05/2006 Last patient last visit = 14/04/2009 Location = radiological department (Hospitals)
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| ID | Title | Description |
|---|---|---|
| FG000 | Xenetix | Patient will receive one injection of Xenetix 300 |
| FG001 | Visipaque | Patient will receive one injection of Visipaque 270 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xenetix | Patient will be injected with Xenetix 300 |
| BG001 | Visipaque | Patient will be injected with Visipaque 270 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Creatinine Clearance | The variation of creatinine clearance before and after the product injection was measured | Posted | Mean | Standard Deviation | percent change | between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xenetix | Patient will be injected with Xenetix 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery of vesical wound | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne DUBOURDIEU | GUERBET | +33.1.45.91.50.00 | corinne.dubourdieu@guerbet-group.com |
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| ID | Term |
|---|---|
| C093233 | iobitridol |
| C044834 | iodixanol |
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| Drug |
270 mg of iodine/ml |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
| 5 |
| 74 |
| 11 |
| 74 |
| EG001 | Vispaque | Patient will be injected with Visipaque 270 | 4 | 71 | 13 | 71 |
| Myelofibrosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Meningitis | Nervous system disorders | Systematic Assessment |
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| Ent surgery | Surgical and medical procedures | Systematic Assessment |
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| Mastoidectomy | Surgical and medical procedures | Systematic Assessment |
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| Operation of the mediastinal haematoma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Abdominal operation | Surgical and medical procedures | Systematic Assessment |
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| Inflammatory syndrome | General disorders | Systematic Assessment |
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| Pyramidal syndrom | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Increase of creatinine | Investigations | Systematic Assessment |
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| Allergic cutaneous reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cutaneous eruption | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Leukoencephalopathy | Nervous system disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | Systematic Assessment |
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| Extravasation | General disorders | Systematic Assessment |
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| Oedema neck and face | General disorders | Systematic Assessment |
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| Tracheitis | Infections and infestations | Systematic Assessment |
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| Vagal discomfort | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Warmth at the site of injection | General disorders | Systematic Assessment |
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| Red papules on the arm | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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