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

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00245505

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: Mesalazine (Mesalamine)	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Endoscopy

Drug Information available for: Mesalamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CDAI changes and laboratory changes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Pentasa (mesalazine) sachets 2 g morning + 2 g evening during 12 weeks treatment

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

4.3 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. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245505

Locations

Sweden, MALMÖ
Department of Medicine, Malmö University Hospital
Malmo, MALMÖ, Sweden, SE-205 02

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Principal Investigator:

Toth Ervin, MD

Malmö University Hospital, MALMO

More Information

Responsible Party:	IPC ( Klas Radberg, International Clinical Trial Manager )
Study ID Numbers:	FE 999907 CS004
Study First Received:	October 26, 2005
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00245505
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009