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

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Mesalazine (Mesalamine)
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine, Malmö University Hospital

Outcomes

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

Secondary Outcome Measures

CDAI changes and laboratory changes

Full Information

First Posted
October 26, 2005
Last Updated
March 9, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00245505
Brief Title
The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to lack of eligible patients
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mesalazine (Mesalamine)
Intervention Description
Pentasa (mesalazine) sachets 2 g morning + 2 g evening during 12 weeks treatment
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
CDAI changes and laboratory changes
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Department of Medicine, Malmö University Hospital
City
Malmo
State/Province
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden

12. IPD Sharing Statement

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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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