|
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:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00209300 |
|
Date of registration:
|
13/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
|
|
Scientific title:
|
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily |
|
Date of first enrolment:
|
May 2005 |
|
Target sample size:
|
362 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00209300 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Belgium
|
Czech Republic
|
Denmark
|
Finland
|
Germany
|
Netherlands
|
Norway
|
Sweden
|
|
Contacts
|
|
Name:
|
Clinical Development Support |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Ferring Pharmaceuticals |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Patients have an established diagnosis of ulcerative colitis and are in clinical
remission with an UC-DAI < 2 at enrollment
2. Extension of the disease > 15 cm distance from anal verge
3. Patients who have had a clinical relapse within the past year. Clinical relapse is
defined as activity of the disease for which maintenance therapy had to be adjusted.
4. Patients on oral mesalazine maintenance therapy = 2.5 grams per day
5. 18 years or older
6. Signed informed consent
Exclusion Criteria:
1. Patients with evidence of other forms of inflammatory bowel disease, idiopathic
proctitis or infectious disease
2. Patients allergic to acetylsalicylic acid and other salicylate derivates aspirin or
salicylates derivatives
3. Patients who used mesalazine > 2.5 grams orally in the previous month,
4. Patients who used rectal mesalazine > 3 grams per week in the previous month
5. Use of corticosteroids (oral and/or rectal routes) within the last month
6. Intake of immunosuppressants within the last 3 months
7. Patients with (known) significant hepatic (up to 2 x upper limit of normal) or
(known) renal function abnormalities, to 1.5 x upper limit of normal values
8. Patients with history or physical examination findings indicative of active alcohol
or drug abuse
9. Patients with a history of disease, including mental/emotional disorders, that would
interfere with their participation in the study
10. Women who are pregnant or nursing (non-menopausal women who are sexually active and
do not use effective contraceptives, as judged by the investigator, must have a
negative pregnancy test)
11. Patients who participated in another clinical study in the last 3 months
12. Patients who were previously participating in this study
13. Patients with any other disease that may influence the study assessment, such as
malignant disease, etc.
14. Patients who are unable to comply with any requirements of the protocol
15. Patients who are unable to write or read local language.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative Colitis
|
|
Intervention(s)
|
|
Drug: Pentasa
|
|
Secondary ID(s)
|
|
2004-004565-15
|
|
FE999907 CS003
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|