E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 4.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009900 |
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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 establish that remission in UC with a once daily oral treatment with 2 gram Pentasa® prolonged release granules per day is non-inferior to a twice daily oral scheme with 1 gram Pentasa® prolonged release granules. Primary Objective To demonstrate that 2 gram mesalazine once daily is non-inferior to 1 gram mesalazine twice daily in terms of the maintenance of remission rate in patients with quiescent ulcerative colitis.
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E.2.2 | Secondary objectives of the trial |
To compare between the two groups • Compliance • Time to relapse • Severity of relapse • Endoscopic evaluation • Average of UC-DAI* at each visit • Acceptability • Safety
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
INCLUSION CRITERIA: 1. Patients have an established diagnosis of ulcerative colitis and are in clinical remission with an UC-DAI < 2 at enrolment, 2. Extension of the disease > 15 cm distance from anal verge, 3. Patients who have had a clinical relapse within the past year. Clinical relapse is defined as activity of the disease for which maintenance therapy had to be adjusted, 4. Patients on oral mesalazine maintenance therapy ≤ 2.5 gram per day, 5. 18 years or older, 6. Signed informed consent.
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E.4 | Principal exclusion criteria |
EXCLUSION CRITERIA: 1. Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease, 2. Patients allergic to acetylsalicylic acid and other salicylate derivates, 3. Patients who used mesalazine > 2.5 grams orally in the previous month, 4. Patients who use rectal mesalazine > 3 grams per week in the previous month, 5. Use of corticosteroids (oral and/or rectal routes) within the last month, 6. Intake of immunosuppressants within the last 3 months, 7. Patients with (known) significant hepatic (up to 2 x upper limit of normal) or (known) renal function abnormalities, to 1.5 x upper limit of normal values 8. Patients with history or physical examination findings indicative of active alcohol or drug abuse, 9. Patients with a history of disease, including mental/emotional disorder, that would interfere with their participation in the study, 10. Women who are pregnant or nursing (non-menopausal women who are sexually active and use not effective contraceptives as judged by the investigator must have a negative pregnancy test), 11. Patients who participated in another clinical study in the last 3 months, 12. Patients who were previously participating in this study, 13. Patients with any other disease that may influence the study assessment, such as malignant disease etc, 14. Patients who are unable to comply with any requirements of the protocol, 15. Patients who are unable to write or read local language.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Objective To establish that maintenance of remission in UC with 2 gram Pentasa® sachets per day is non-inferior to a twice daily oral scheme with 1 gram Pentasa® sachets. |
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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 | Yes |
E.6.4 | Safety | Yes |
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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Yes |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | 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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End of trial is last visit after 12 months of treatment or at the occurence of relapse. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |