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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048928 |
E.1.2 | Term | Colitis collagenous |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 |
The main objective of the trial is to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period. |
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E.2.2 | Secondary objectives of the trial |
- To study safety and tolerability in the form of adverse events and laboratory parameters - To assess patients' health-related quality of life (SHS and PGWB) under maintenance therapy with budesonide |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients aged >= 18 years, - Histologically established diagnosis of collagenous colitis (CC) defined as: a) Thickened sub-epithelial collagen layer >= 10 µm on well-orientated sections b) Increased amount of inflammatory cells indicating chronic inflammation in the lamina propria - History of non-bloody, watery diarrhoea for more than 2 weeks prior screening in patients with nexly diagnosed collagenous colitis, or history of clinical relapse for more than 1 week prior screening in patients with previously established collagenous colitis - A mean of >= 3 stools/day, thereof a mean of >= 1 watery stolls/day, during the week prior baseline (not applicable for patients having participated in study BUC-60/COC and having been open-labelled treated with 9 mg budesonide OD for 4 weeks under the protocol BUC-60/COC in case of non-response during double-blind treatment or for a relapse during the follow-up period, who are allowed to enter the open-label phase of BUC-63/COC at the -4-week visit and continue with the open-label instruction regimen for period week 5-8. |
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E.4 | Principal exclusion criteria |
- Other significant abnormalities at colonoscopy that may have been the cause of diarrhoea, with the exception of colonic diverticulosis and polyps < 2 cm - Infectious cause of diarrhoea - Untreated active celiac disease - Clinical suspicion of drug-induced collagenous colitis - Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder - Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal ULN), liver cirrhosis, or portal hypertension - Local intestinal infection - Radiation therapy towards the abdominal or pelvic region - Diabetes mellitus, infection, glaucoma, tuberculosis, peptic uler disease, or hyper- tension if careful medical monitoring is not ensured - Known established cataract - Established osteoporosis with T-score < -2.5 - Pregnancy or lactation - History of cancer in the past five years - History of significant bowel resection - Therapy with immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate) in the last 3 months - Treatment with oral, rectal, or intravenous corticosteroids incl. budesonide in the last month |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients being in remission over 52 weeks, with remission defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day. |
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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 | 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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Open: during induction phase, double-blind: maintenance treatment phase |
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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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 | Yes |
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
|
The end of the trial is defined as 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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |