Clinical trial NCT00862121: A Study With Pentasa in Patients With Active Crohn's Disease
Official title: PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn´s Disease
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.
timeFrame: At Week 10, end of treatment
Secondary outcomes:
measure: Relative Change From Baseline to Week 10 in Fecal Calprotectin
timeFrame: At Week 10, end of treatment
measure: Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)
timeFrame: Within the 10 week treatment period
measure: Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
timeFrame: Within the 10 week treatment period
measure: Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)
timeFrame: Within the 10 week treatment period
measure: Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance
timeFrame: At Week 10, end of treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: John's Creek
country: United States
facility: Atlanta Gastroenterology Specialists
state: Georgia
city: Mexico
country: United States
facility: Center for Digestive and Liver Disease, Inc
state: Montana
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research Inc.
state: Ohio
city: Anderson
country: United States
facility: Hartwell Research Group, LLC
state: South Carolina
city: Liège
country: Belgium
facility: CHC Saint Joseph
city: Copenhagen
country: Denmark
facility: Herlev University Hospital
city: Lille
country: France
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Köln
country: Germany
facility: Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis
city: Lund
country: Sweden
facility: Lunds Lasaret
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: