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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
EUCTR2007-000842-11-AT |
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Date of registration:
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04/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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99Tc labled Inliximab for evaluation of inflammatory activity in patients with inflammtory bowel disease (IBD)
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Scientific title:
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99Tc labled Inliximab for evaluation of inflammatory activity in patients with inflammtory bowel disease (IBD) |
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Date of first enrolment:
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15/10/2007 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000842-11 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: endoscopy
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
active inflammatory bowel disease
age over 18 years
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
immune deficiency, allergy to infliximab, malignancy, severe infections, pregnancy
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Inflammatory bowel disease
Crohn´s disease
Ulcerative colitis
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Intervention(s)
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Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277313
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Primary Outcome(s)
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Main Objective: Comparison of szintigraphy using 99Tc labled infliximab for evaulation of inflammatory activity in patients with IBD inflammation seen by routine endoscopy
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Primary end point(s): Comparison of szintigraphy using 99Tc labled infliximab for evaulation of inflammatory activity and localisation in patients with active IBD. Results will be compared to inflammation seen by routine endoscopy.
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Secondary Objective:
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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