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| ID | Type | Description | Link |
|---|---|---|---|
| 309660 | Other Identifier | company internal |
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This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician.
Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iopromide 370 mg I/mL | Experimental | Iopromide (Ultravist 370 mg I/mL) administered intravenously |
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| Iopromide 300 mg I/mL | Experimental | Iopromide (Ultravist 300 mg I/mL) administered intravenously |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iopromide 370 mg I/mL | Drug | Iopromide (Ultravist 370 mg I/mL) administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor. | post administration assessment of study images |
| Measure | Description | Time Frame |
|---|---|---|
| The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | The number of participants with diagnostic CECTs as assessed by the investigators. | post administration assessment of study images |
| The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85711 | United States | |||
437 subjects were screened; 2 subjects were screen failures because of not meeting inclusion criteria and/or meeting exclusion criteria; 435 subjects were enrolled; 1 enrolled subject withdrew consent before receiving study drug; 434 subjects received study drug and were included in the safety analysis set.
The recruitment period was 21 Oct 2005 to 11 Apr 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iopromide 370 mg I/mL | Iopromide (Ultravist 370 mg I/mL) administered intravenously |
| FG001 | Iopromide 300 mg I/mL | Iopromide (Ultravist 300 mg I/mL) administered intravenously |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Iopromide 300 mg I/mL | Drug | Iopromide (Ultravist 300 mg I/mL) administered intravenously |
|
A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor. |
| post administration assessment of study images |
| The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | The number of participants with diagnostic CECTs as assessed by the 3 blinded readers. | post administration assessment of study images |
| Miami |
| Florida |
| 33101 |
| United States |
| Tallahassee | Florida | 32308 | United States |
| Atlanta | Georgia | 30303 | United States |
| Atlanta | Georgia | 30322 | United States |
| Evanston | Illinois | 60201 | United States |
| Baltimore | Maryland | 21287 | United States |
| Boston | Massachusetts | 02114-2696 | United States |
| Boston | Massachusetts | 02115 | United States |
| Boston | Massachusetts | 02118 | United States |
| Ann Arbor | Michigan | 48109-0030 | United States |
| Detroit | Michigan | 48201 | United States |
| New York | New York | 10016 | United States |
| Stony Brook | New York | 11794-8460 | United States |
| Cleveland | Ohio | 44195 | United States |
| Danville | Pennsylvania | 17822 | United States |
| Charleston | South Carolina | 29425 | United States |
| MedellÃn | Antioquia | Colombia |
| Bogotá | Colombia |
| Mumbai-400026 | India |
| Tamil Nadu | India |
| Seoul | Seoul Teugbyeolsi | 110-744 | South Korea |
| Seoul | 138-736 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Iopromide 370 mg I/mL | Iopromide (Ultravist 370 mg I/mL) administered intravenously |
| BG001 | Iopromide 300 mg I/mL | Iopromide (Ultravist 300 mg I/mL) administered intravenously |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. | A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor. | The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included. | Posted | Number | Number of participants in QOI grade | post administration assessment of study images |
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| Secondary | The Ability of the Investigator to Make a Diagnosis Based on the CECT Images | The number of participants with diagnostic CECTs as assessed by the investigators. | The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included. | Posted | Number | Number of diagnostic CECTs | post administration assessment of study images |
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| Secondary | The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment. | A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor. | The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included. | Posted | Number | Number of participants in QOI grade | post administration assessment of study images |
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| Secondary | The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images | The number of participants with diagnostic CECTs as assessed by the 3 blinded readers. | The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included. | Posted | Number | Number of diagnostic CECTs | post administration assessment of study images |
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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 | Iopromide 370 mg I/mL | Iopromide (Ultravist 370 mg I/mL) administered intravenously | 2 | 412 | 32 | 412 | ||
| EG001 | Iopromide 300 mg I/mL | Iopromide (Ultravist 300 mg I/mL) administered intravenously | 0 | 22 | 1 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Feeling Hot | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Haemoglobin increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| C038192 | iopromide |
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| Male |
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| Excellent + Good (blinded reader 2) |
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| Poor (blinded reader 2) |
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| Excellent + Good (blinded reader 3) |
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| Poor (blinded reader 3) |
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| Percent Images Rated Good/Excellent: BR2 |
| 96.3 |
| 95 |
| 93.9 |
| 98.0 |
| No |
| Superiority or Other |
| Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3). | Percent Images Rated Good/Excellent: BR3 | 98.4 | 95 | 96.6 | 99.4 | No | Superiority or Other |
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