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Main
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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00245505 |
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Date of registration:
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26/10/2005 |
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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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The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"
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Scientific title:
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The Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot Study |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00245505 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Clinical Development Support |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ferring Pharmaceuticals |
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Key inclusion & exclusion criteria
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4.2 Inclusion Criteria
1. Patients who have signed the informed consent form
2. Patients with performed complete VCE < 7 days prior to inclusion and diagnosed
clinically active mild to moderate small bowel CD and no stricture on previous
examinations, as previously proven by barium small bowel follow through, enteroclysis
and / or patency test capsule.
3. Patients between 18 - 70 years of age.
4.3 Exclusion Criteria
1. Patients with evidence of other forms of inflammatory small bowel bowel disease,
idiopathic proctitis or infectious disease.
2. Patients with known small bowel strictures from previous examinations with for
instance barium small bowel follow through, enteroclysis and / or patency capsule
test.
3. Patients with pacemaker due to lack of VCE interaction data.
4. Patients who cannot undergo study procedures due to swallowing disorders.
5. Planned or actual pregnancy or lactation.
6. Women of child-bearing potential who are not using an effective method of
contraception, in the opinion of the investigator.
8. Patients receiving maintenance treatment (p.o.) with total daily doses above 2.0g of
sulphasalazine, mesalazine or 4-ASA, for 30 days prior to entry into the study.
9. Chronic use of non-steroidal anti-inflammatory drugs (oral and/or rectal routes) in 30
days prior to inclusion in the study (chronic use is defined as drug intake for a
minimum of 3 consecutive days).
10. Intake of corticosteroids (oral and/or rectal routes) within the 30 days prior to
enrolment in the study.
11. Patients receiving any immunosuppressive (azathioprine, 6-MP, etc) agents during 30
days prior to study enrolment.
12. Patients receiving any Crohn specific biological agents (TNF-alfa) during the last
year prior to study enrolment.
13. Patients with any other disease or condition which may interfere with study
assessments as judged by the investigator.
14. Alcoholism or drug addiction. 15. Patients participating or having participated in
another clinical study in the previous 30 days.
16. Patients with severe renal/hepatic impairment (see section 5.6) as judged by the
investigator.
17. Patients who are allergic to salicylate or 5-ASA derivatives. 18. Patients who are
unlikely to comply with the protocol. 19. Any patient who has previously taken part in
this study. 20. Patients who are unable to write or read local language
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Mesalazine (Mesalamine)
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Primary Outcome(s)
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Mucosal changes, (measured as number, type and localization of small bowel mucosal lesions detected by VCE) from baseline (i.e. < 7 days prior to inclusion), and after 6 and 12 weeks´ treatment with 4g Pentasa Sachet
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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CDAI changes and laboratory changes
[Time Frame: 12 weeks]
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Secondary ID(s)
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FE999907 CS004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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URL:
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