E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ulcerative colitis patients in clinical remission |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
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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 confirm Myrrhinil-Intest's non-inferiority versus mesalazine concerning the activity of ulcerative colitis in remission over the treatment period.
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E.2.2 | Secondary objectives of the trial |
Efficacy parameters: Duration until relapse; general condition assessment by the physician and patient; social activity of the patient; constitution of the patient; efficacy assessment by the physician; quality of life; inflammatory parameters: lactoferrine, pmn elastase and calprotectin; mucosal healing; histologic healing
Safety parameters: adverse events; blood count: CRP, leukocytes, thrombocytes, Hb, serum creatinine, AST and ALT, blood sedimentation rate; vital signs; tolerance of the investigational product; occurrence of relapses in patients; relapse rate |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: Investigation of predictive factors for relapse and non-invasive fecal markers in monitoring of patients with ulcerative colitis - a prospective longitudinal study over 6 months
Date: 16-06-2008
Version: 1.0
Objectives: The aim of the study is to investigate predictive factors for relapse and faecal parameters as non-invasive markers in monitoring of patients with ulcerative colitis. Furthermore it is to be determined if the extent of chronic stress, cell structures or genetic patterns differ significantly between the groups of variable clinical courses. |
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E.3 | Principal inclusion criteria |
-patients of both gender, ≥ 18 years of age -patients diagnosed with ulcerative colitis (clinical, endoscopic, histological) and in remission between 1 week and 1 year according to colitis activity index (CAI, defined by Rachmilewitz) ≤ 4 at enrollment -signed informed consent
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E.4 | Principal exclusion criteria |
-use of steroids or antibiotics for ulcerative colitis together with the investigational procuct -intake of Escherichia coli Nissle and Psyllii semen together with the investigational product -administration of the following drugs within the previous 3 months before trial entry and during the trial: 'biologicals' (Infliximab, Mycophenolat, Tacrolimus, Thalidomid), other drugs to modify immune response (Methotrexat, Azathioprin) or/and drugs in clinical development -total parenteral nutrition, formula diet -infectious or chronic active ulcerative colitis -active ulcerative colitis at trial entry -condition after complete colectomy -malignant tumor disease within the last 5 years and/or malignant tumor disease older than 5 years which can not be considered cured according to the investigator's judgement (except superficial basal cell, squamous cell carcinoma, or basalioma of the skin which has been completely resected or can be considered cured) or/and clinical significant cardiac, hepatic or renal dysfunctions or diseases of the CNS, lung, immune system or gastro-intestinal diseases (in addition to ulcerative colitis) -known alcohol or drug abuse -known intolerance to the ingredients -pregnancy or in the physician's opinion unreliable contraception for women of childbearing years
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the averaged colitis activity index (defined by Rachmilewitz) of a patient over the treatment period. |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | 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
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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 | |