NCT00245505TerminatedPhase 3
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
Ferring Pharmaceuticals2 sites in 1 country3 target enrollmentStarted: February 1, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
Brief Summary
The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy.
Detailed Description
The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •4.2 Inclusion Criteria
- •Patients who have signed the informed consent form
- •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.
- •Patients between 18 - 70 years of age.
Exclusion Criteria
- •Patients with evidence of other forms of inflammatory small bowel bowel disease, idiopathic proctitis or infectious disease.
- •Patients with known small bowel strictures from previous examinations with for instance barium small bowel follow through, enteroclysis and / or patency capsule test.
- •Patients with pacemaker due to lack of VCE interaction data.
- •Patients who cannot undergo study procedures due to swallowing disorders.
- •Planned or actual pregnancy or lactation.
- •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.
- •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.
- •Patients who are unlikely to comply with the protocol.
- •Any patient who has previously taken part in this study.
- •Patients who are unable to write or read local language
Outcomes
Primary Outcomes
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
Secondary Outcomes
- CDAI changes and laboratory changes(12 weeks)
Investigators
Study Sites (2)
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