PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo
- Conditions
- Active mild to moderate crohn's disease.MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
- Registration Number
- EUCTR2008-002100-26-FR
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 510
At Visit 1 (screening visit)
• Signed written informed consent obtained before conduction of any trial related procedures
• Age; 18 years or above
• CD symptoms/onset of disease: 3 months = CD duration = 3 years
• 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) at any time since the disease was diagnosed
• A Harvey-Bradshaw score between 5 and 12
• Males and non-pregnant, non-nursing women. Female patients should have cessation of regular menses for more than 12 months, be surgically sterile, or be using medically approved contraception, throughout the trial period.
At Visit 2 (randomisation visit)
• 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)
• Hemoglobin value above 100 g/L
• Values of aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (ALP), and/or bilirubin not more than 2 times upper limits of normal (ULN)
• Serum creatinine below ULN
• Normal values of proteinuria and leucocyturia (=0/+)
• Compliant with requirements to disallowed medications and other restrictions (see Section 4.3 of the Clinical Trial Protocol)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
At Visit 1 (screening visit)
• 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
• Ileostomy, ileo-pouch-anal anastomosis, ileorectal anastomosis, subtotal coloectomy and/or proctocoloectomy
• Fistulas (external/internal and/or abscess)
• Strictures (characterised by abdominal pain/cramping with radiologic/MRI/US stenosis with prestenotic dilatation or endoscopic stenosis not passable for the endoscope)
• CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine.
• CD isolated to colon below the left colon flexure and/or isolated proctitis and/or anal disease
• Prior treatment resistance to mesalazine
• Current relapse lasting more than six weeks (according to the patient)
• Evidence of other forms of inflammatory bowel disease (IBD) or infectious disease
• Hepatic (including sclerosing cholangitis) or renal functioning abnormalities
• Septic complication, abscess, perforation or obstruction
• Need for immediate surgery or unlikely to complete the trial due to poor general condition
• Documented histological gastrointestinal malignancy or high-grade dysplasia and/or other malignant disease (excluding basal and squamous skin cell carcinoma) within the last five years prior to entering the trial
• Uncontrolled diabetes
• Rheumatoid arthritis
• Known Human Immunodeficiency Virus (HIV) infection or at high risk for HIV infection
• Allergy to aspirin or salicylate derivatives
• History of known hypersensitivity to the excipients used in the investigational medicinal products (IMPs)
• Continuous usage of steroids for 3 months or more within the last 3 years
• Any previous use of biologics (e.g. anti-TNF-a)
• Palpable abdominal mass
• Chronic, dominant arthralgia
• Involvement in the planning and conduct of the trial (applies to staff at trial site, MDS Pharma Services, ClinPhone, and Ferring)
• Participation in another clinical trial within the last 3 months prior to enrolment
• Alcohol or drug abuse or any other condition associated with poor compliance or other reason for not being appropriate for the trial, in the opinion of the Investigator
• Previous randomisation in the present trial
At Visit 2 (randomisation visit)
• Stool culture showing unwanted pathogens such as: Salmonella, Shigella, Campylobacter and/or Clostridium difficile
• Patients who are unable to comply with the requirements of the protocol
• Positive pregnancy test
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method