Status:
TERMINATED
A Study With Pentasa in Patients With Active Crohn's Disease
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Crohn´s Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.
Eligibility Criteria
Inclusion
- Inclusion Criteria (main):
- Age: at least 18 years
- CD symptoms/onset of disease: ≥ 3 months prior to Visit 1
- Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease
- A confirmed location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy)
- A Harvey-Bradshaw score between 5 and 12
- Males and non-pregnant, non-nursing women
- Mild to moderate active CD, defined by a CDAI score between 180 and 350
- Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g)
- Estimated creatinine clearance should be above 75 ml/min
- Exclusion Criteria (main):
- Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient's ability to participate in the trial
- CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine, and/or to colon below the left colon flexure and/or isolated proctitis and/or anal disease
- Prior treatment resistance to Pentasa (mesalazine)
- Chronic, dominant arthralgia or rheumatoid arthritis
- Palpable abdominal mass
- Biologics (eg anti-TNF-α) must not be used during the trial or 6 months before Visit 1
- Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year
- Positive pregnancy test
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00862121
Start Date
April 1 2009
End Date
October 1 2010
Last Update
March 16 2012
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
San Diego Clinical Trials
San Diego, California, United States
2
Clinical Research of West Florida
Clearwater, Florida, United States
3
Atlanta Gastroenterology Specialists
John's Creek, Georgia, United States
4
Center for Digestive and Liver Disease, Inc
Mexico, Montana, United States