The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00245505
• Other study ID #: FE999907 CS004
• Status: Terminated
• Phase: Phase 3
• First received: October 26, 2005
• Last updated: March 9, 2012
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: March 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Mesalazine (Mesalamine)
Pentasa (mesalazine) sachets 2 g morning + 2 g evening during 12 weeks treatment

Locations

Country	Name	City	State
Sweden	Department of Medicine, Malmö University Hospital	Malmo	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 weeks	No
Secondary	CDAI changes and laboratory changes		12 weeks	No