E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate active Crohn's disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
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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 visualize the healing effect on mucosal lesions with Pentasa Sachet 4 g in patients with mild to moderate active small bowel CD. |
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E.2.2 | Secondary objectives of the trial |
CDAI changes, laboratory changes |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients who have signed the informed consent form Patients with performed complete VCE≤7 days prior to inclusion and diagnosed clinically active mild to moderate small bowel CD and no stricture on previous exaninations, as previously proven by barium small bowel follow through, enteroclysis and / or patency test capsule and with visualization of the entire small bowel. Patients between 18 - 70 years of age |
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E.4 | Principal exclusion criteria |
1. Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease. 2. Patients with known strictures from previous examinations with for instance barium small bowel follow through, enteroclysis and / or patency capsule test. 3. Patients with laboratory values outside normal ranges according to the clinic routines. 4. Patients with pacemaker due to lack of VCE interaction data. 5. Patients who cannot undergo study procedures due to swallowing disorders. 6. Planned or actual pregnancy or lactation.
7. Women of child-bearing potential who are not using an effective method of contraception, in the opinion of the investigator.
8. Patients receiving maintenance treatment (p.o.) with total daily doses above 2.0g of sulphasalazine, mesalazine or 4-ASA, for 30 days prior to entry into the study.
9. Chronic use of non-steroidal anti-inflammatory drugs (oral and/or rectal routes) in the seven days prior to inclusion in the study (chronic use is defined as drug intake for a minimum of 3 consecutive days).
10. Intake of corticosteroids (oral and/or rectal routes) within the 30 days prior to enrolment in the study.
11. Patients receiving any immunosuppressive (azathioprine, 6-MP, etc) agents during 30 days prior to study enrolment.
12. Patients receiving any Crohn specific biological agents (TNF-alfa) during the last year prior to study enrolment.
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E.5 End points |
E.5.1 | Primary end point(s) |
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 Pentasa Sachet 4 g. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.1.7.1 | Other trial design description |
investigator blinded, prospective, uncontrolled pilot study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |