E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302. Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study |
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MedDRA Classification |
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 assess the safety and tolerability od SPD476 2.4 g/day (2.4 g dosed once daily) and SPD476 2.4 g/day (1.2 g dosed twice daily) in long-term (12 month)study |
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E.2.2 | Secondary objectives of the trial |
Acute Phase: 1.To evaluate the percentage of subjects in the Acute Phase who are in remission(a UC-DAI score of <1 , with a score of 0 for rectal bleeding and stool frequency, and at least a 1-point reduction from the Study 301 or 302 baseline in the sigmoidoscopy score) at the end of the treatment period with SPD476 4.8 g/day (2.4 g dosed twice daily) 2.To assess the safety and tolerability of SPD476 4.8 g/day (2.4 g dosed twice daily) Maintenance Phase: 1.To compare subject compliance between SPD476 2.4 g/day (2,4 g dosed once daily) and SPD476 2.4 g/day (1.2 g dosed twice daily). 2.To compare the time to relapse between SPD476 2.4 g (2.4 g dosed once daily) and SPD476 2.4 g/day (1.2 g dosed twice daily) over 12 months. 3.To compare the percentage of subjects in remission at the end of the 12 month treatment period between SPD476 2.4 g (2.4 g dosed once daily) and SPD476 2.4 g/day (1.2 g dosed twice daily). 4.To compare Patient Questionnaire scores between treatment groups. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects must sign the study 303 informed consent form, meet all eligibility requirements and have completed all assessments of the Study 301 or 302 End of Study /Early Withdrawal Visit. Women of child bearing potential (WOP) must use an acceptable contraceptive method while the subject is on the study treatment. Subject and investigator must egree that participation in the Acute and/or Maintenance Phase of this study is in the best interest of the subject |
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E.4 | Principal exclusion criteria |
Subject who have withdrawn from Study 301 or 302 before study visit 3, or subject who withdrew from Study 301 or 302 due to a possibly or probably related severe AE or SAE are not eligible to enter this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability will be assesed by EAs, laboratory testing (hematology and biochemistry) urinalysis, physical examination and vital signs. Remission is defined as a UC-DAI of <1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction the sigmoidoscopy score from baseline of Study 301 or 302. Compliance will assessed by counting the number of tablets dispensed to the subjects and counting the number of tablets returned |
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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 | Yes |
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) | 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 | Yes |
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.8.2 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | 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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last visit of the last subject |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |