E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active ulcerative colitis |
aktīvs čūlainais kolīts |
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E.1.1.1 | Medical condition in easily understood language |
Active ulcerative colitis |
aktīvs čūlainais kolīts |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
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 proof the non-inferiority of an 8-week treatment with three times daily 1000mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis |
pierādīt, ka 8 nedēļas ilga aktīvā čūlainā kolīta ārstēšana ar 1000 mg mesazalīna trīs reizes dienā ir līdzvērtīga 8 nedēļu ilgai ārstēšanai ar 2x500 mg mesazalīna trīs reizes dienā |
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E.2.2 | Secondary objectives of the trial |
- To study safety and tolerability - To assess patients' acceptance and preference of trial drugs - To assess patients' quality of life |
- pēc nevēlamām blakusparādībām un laboratorijas rādītājiem noteikt zāļu drošību un panesamību; - novērtēt, cik labi pacienti panes pētāmās zāles un, kurām zālēm dod priekšroku; - novērtēt pacientu dzīves kvalitāti.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed informed consent, 2. Men or women aged 18 to 75 years, 3. Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology, |
1. parakstīta informētā piekrišana; 2. vīrieši un sievietes vecumā no 18 līdz 75 gadiem; 3. aktīvs čūlainais kolīts, ar proktīta ierobežojumu 15 cm ab no, ko apliecina endoskopija un histoloģija;
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E.4 | Principal exclusion criteria |
1. Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), 2. Toxic megacolon, 3. Screening stool positive for germs causing bowel disease, 4. Malabsorption syndromes, 5. Celiac disease, 6. Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding, |
1. Krona slimība, neprecizēts kolīts, išēmiskais kolīts, radiācijas izraisīts kolīts, ar divertikulāro slimību saistīts kolīts, mikroskopiskais kolīts (t.i., kolagēnais kolīts un limfocitārais kolīts); 2. toksiskais megakolons; 3. izkārnījumu analīžu rezultāti uzrāda zarnu slimības izraisošas baktērijas; 4. Malabsorbcijas sindroms; 5. Celiakija; 6. citas resnās zarnas un zarnu iekaisuma vai asins nesarecēšanas slimības vai slimības, kas var izraisīt caureju vai gastrointestinālu asiņošanu; |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of clinical remission after 8 weeks |
Klīniskās remisijas ātrums 8. nedēļā |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 8 weeks of treatment |
Pēc 8 terapijas nedēļām |
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E.5.2 | Secondary end point(s) |
Rate of clinical improvement (CAI) Number of stools per week Number of bloody stools per week Number of days with urgency per week Time to first resolution of clinical symptoms Patient’s Quality of Life Patient’s Global Satisfaction Patient’s acceptance and preference of trial drug Physician's Global Assessment Adverse Events (AEs) Vital signs (blood pressure, heart rate) and body weight Laboratory assessments
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Klīniskā stāvokļa uzlabošanās ātrums (KAI) Izkārnījumu skaits nedēļā Asiņainu izkārnījumu skaits nedēļā Dienu skaits, kad steidzami nepieciešams apmeklēt tualeti Laika periods, līdz parādās pirmie klīniskie simptomi Pacienta dzīves kvalitāte Pacienta vispārējā apmierinātība Cik labi pacients panes izmēģinājuma zāles un kurām dod priekšroku Terapeita vispārējais pacienta novērtējums Nevēlamas blakusparādības Organisma stāvokļa galvenie rādītāji (asinsspiediens, sirdsdarbība) un ķermeņa svars Laboratorijas rādītāji |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Each visit, if not otherwise defined |
Katra vizīte, ja citādi nav noteikts |
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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 |
divkārtslēpts |
double-dummy |
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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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 | No |
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 |
Russian Federation |
Ukraine |
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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
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The study end is defined as "last patient out" (LPO), i.e. "last patient having his/her last visit" |
Pētījums skaitās pabeigts, kad ir notikusi pēdēja pacienta pēdēja vizīte |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |