|
Main
|
|
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. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
19 March 2012 |
|
Main ID: |
EUCTR2010-018557-35-NL |
|
Date of registration:
|
11/02/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazine
|
|
Scientific title:
|
Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazine |
|
Date of first enrolment:
|
08/11/2010 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018557-35 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Age> 16 years.
2. History of ulcerative colitis (active or in remission).
3. Presumed history of intolerance (diarrhea, urticaria, fever, acute pancreatitis or elevated c-reactive protein) for any 5-ASA drugs.
4. Informed consent.
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:
1. History of intolerance with the following reactions; interstitial nephritis, anaphylactic shock or bullous skin reations.
2. Pregnancy or fertile women without adequate anticonception.
3. Renal dysfunction (diminished eGFR <40ml/min)
4. Poor mental health.
5. No informed consent.
6. Non compliance.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative colitis
|
|
Intervention(s)
|
Trade Name: Mesalazine
Product Name: Mesalazine
Product Code: Salofalk
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
|
Main Objective: To investigate whether patients with known intolerance for mesalazine, can be desensitizied for mesalazine.
|
|
Primary end point(s): 1. Successful desensitization for mesalazine in patients with a presumed history of intolerance for mesalazine.
|
|
Secondary Objective: To investigate if a presumed history of intolerance will be reproducible in a clinical setting.
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|