E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048928 |
E.1.2 | Term | Colitis collagenous |
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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 compare the efficacy of budesonide (9 mg budesonide/d) vs. mesalazine granules (3 g 5-ASA/d) vs. placebo for the treatment of collagenous colitis. |
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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' quality of life |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- > 4 watery/soft stools on at least 4 days in the week prior to baseline (antidiarrheals have to be discontinued 2 weeks before baseline) - > 3 stools per day on average within the last 7 days prior to baseline - Symptoms (chronic watery diarrhea) for at least 3 months before baseline - Complete colonscopy within the last 12 weeks before baseline - Histologically confirmed diagnosis of collagenous colitis |
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E.4 | Principal exclusion criteria |
- Evidence of infectious diarrhea (i.e., pathogenic bacteria in stool culture or rectal biopsies) - Treatment with antidiarrheals within the last 2 weeks before baseline - Treatment with budesonide, salicylates, Boswellia serrata extract, steroids, antibiotics, cholestyramine, non-steroidal and antiflammatory, or other immunosuppressant drugs within the last 4 weeks before baseline. These drugs are allowed for max. 7 days cumulatively between 4 and 12 weeks prior to baseline, in case, a colonoscopy is performed during this time period. - Treatment with ketoconazole or other CYP3A inhibitors within the last 4 weeks before baseline - Celiac disease (blood tests and/or oesophagogastroduodenoscopy with histological examination to be performed) - Endoscopic-histologic findings, which may have caused diarrhea (i.e., polyps > 2 cm, tumors, Crohn's disease, ulcerative colitis, ischemic colitis - History of partial colonic resection - Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract - Active colorectal cancer or a history of colorectal cancer - Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible. - Severe co-morbidity substantially reducing life expectancy - Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN) - Abnormal renal function (Cystatin C > ULN) - Active peptic ulcer disease, local intestinal infection - Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured - Hemorrhagic diathesis |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of clinical remission ( <= 3 stools per day in the last 7 days) after 8 weeks |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
open-label treatment planned in case of relapse after double-blind treatment phase |
|
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 | Yes |
E.8.2.3.1 | Comparator description |
Both MP are to be compared to placebo |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 | 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 | 4 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |