E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active mild to moderate crohn's disease. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate that a daily dose of 6 g PENTASA Sachet administered as a 2 g morning dose and a 4 g evening dose during a period of 10 weeks is superior to placebo in active mild to moderate CD in terms of response rate (a reduction in Crohn’s Disease Activity Index (CDAI) score to <150 or a decrease in CDAI score of at least 70) |
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E.2.2 | Secondary objectives of the trial |
• Number of patients with sustained remission (defined as a reduction in CDAI score to <150 for at least two weeks) • The onset of response (defined as a reduction in CDAI score to <150 or a decrease in CDAI score of at least 70, whichever is first) • The onset of a reduction in the CDAI score to <150 • The onset of a decrease in CDAI score of at least 70 • The onset of response sustained until Week 10 • The number of weeks in response • Treatment failure • Safety • Quality of Life (QoL) • Work productivity
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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)
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E.4 | Principal exclusion criteria |
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-α) • 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of responders at Week 10. A responder is defined as a patient who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 19 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 19 |