The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A.

• Conditions: Mild to moderate active Crohn's disease; MedDRA version: 7.1Level: PTClassification code 10011401

• Registration Number: EUCTR2005-002472-15-SE
• Lead Sponsor: Ferring Laegemidler A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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 exaninations, as previously proven by barium small bowel follow through, enteroclysis and / or patency test capsule and with visualization of the entire small bowel.
Patients between 18 - 70 years of age
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. Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease.
2.Patients with known strictures from previous examinations with for instance barium small bowel follow through, enteroclysis and / or patency capsule test.
3.Patients with laboratory values outside normal ranges according to the clinic routines.
4.Patients with pacemaker due to lack of VCE interaction data.
5.Patients who cannot undergo study procedures due to swallowing disorders.
6.Planned or actual pregnancy or lactation.

7.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 the seven 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To visualize the healing effect on mucosal lesions with Pentasa Sachet 4 g in patients with mild to moderate active small bowel CD.;Secondary Objective: CDAI changes, laboratory changes;Primary end point(s): 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 Pentasa Sachet 4 g.