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

Phase 3
Terminated
Conditions
Crohn's Disease
Registration Number
NCT00245505
Lead Sponsor
Ferring Pharmaceuticals
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

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
3
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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 Sachet12 weeks
Secondary Outcome Measures
NameTimeMethod
CDAI changes and laboratory changes12 weeks

Trial Locations

Locations (1)

Department of Medicine, Malmö University Hospital

🇸🇪

Malmo, Malmö, Sweden

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