E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute uncomplicated diverticulitis |
Ūminis nekomplikuotas divertikulitas |
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E.1.1.1 | Medical condition in easily understood language |
Acute uncomplicated inflammation of protuberances of the bowel mucosa |
Ūminis nekomplikuotas žarnyno gleivinės išsigaubimų uždegimas |
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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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055777 |
E.1.2 | Term | Diverticulitis of colon (without mention of haemorrhage) |
E.1.2 | System Organ Class | 100000004862 |
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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 |
To compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo, in patients with acute uncomplicated diverticulitis |
Palyginti rifamicino SV-MMX® 400 mg dozės du kartus per dieną, rifamicino SV-MMX® 600 mg dozės tris kartus per dieną ir placebo veiksmingumą, skiriant sergantiesiems ūminiu nekomplikuotu divertikulitu. |
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E.2.2 | Secondary objectives of the trial |
• To assess the optimal dose of Rifamycin SV-MMX® for the treatment of acute uncomplicated diverticulitis • To study safety and tolerability of Rifamycin SV-MMX® vs. placebo in terms of adverse events and laboratory parameters
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• Įvertinti optimalią rifamicino SV-MMX® dozę sergantiesiems ūminiu nekomplikuotu divertikulitu. • Tirti rifamicino SV-MMX® saugumą ir toleravimą, lyginant su placebu, vertinant pagal nepageidaujamus reiškinius ir laboratorinių tyrimų parametrus.
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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 between 18 and 80 years of age, 3. Diagnosis of left-sided uncomplicated diverticulitis 4. Conservative therapy/management indicated, no need for surgery or intervention
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1. Pasirašytas informuoto asmens sutikimas. 2. Vyrai arba moterys nuo 18 iki 80 metų. 3. Patvirtinta kairės pusės nekomplikuoto divertikulito diagnozė 4. Konservatyvaus gydymo/kontroliavimo indikacijos (operacijos ar intervencijos nereikia). |
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E.4 | Principal exclusion criteria |
1. Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation), 2. Right-sided diverticulitis, 3. Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps), 4. Chronic inflammatory bowel disease (such as Crohn`s disease, ulcerative colitis) or celiac disease, 5. Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia), 6. Inability to tolerate oral intake
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1. Esamos divertikulito komplikacijos (divertikulitas, komplikavęsis abscesu, fistule, obstrukcija ar perforacija). 2. Dešinės pusės divertikulitas. 3. Ankstesnė storosios žarnos operacija (išskyrus apendektomiją, hemoroidektomiją ir polipų pašalinimą endoskopu). 4. Lėtinė uždegiminė žarnų liga (pavyzdžiui Krono liga, opinis kolitas) arba celiakija. 5. Esama simptominė organinė virškinamojo trakto liga (išskyrus nekraujuojantį hemorojų arba stemplinės angos išvaržą). 6. Geriamųjų preparatų netoleravimas.
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of patients with treatment success at the day 10 visit |
Pacientų, kuriems 10-osios dienos vizito metu bus nustatytas tiriamojo preparato vartojimo veiksmingumas, dalis. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 10 days of treatment |
Po 10-ties dienų gydymo |
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E.5.2 | Secondary end point(s) |
• Rate of treatment success at V3 and V4 • First visit with treatment success (V3, V4 or V5) • Rate of treatment failure at V3, V4 and V5 • First visit with treatment failure (V3, V4 or V5) • Rate of surgical intervention of acute diverticulitis until V5 and V6 • Rate of antimicrobial treatment due to acute diverticulitis until V5 and V6 • Rate of hospitalisation due to acute diverticulitis until V5 and V6 • Rate of occurrence of complicated diverticulitis until V5 and V6 • Use of rescue therapy until V5
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• Tiriamojo preparato vartojimo veiksmingumo nustatymo dažnumas, vertinant V3 ir V4 metu. • Pirmasis vizitas, kurio metu nustatytas tiriamojo preparato vartojimo veiksmingumas (V3, V4 arba V5). • Tiriamojo preparato vartojimo neveiksmingumo nustatymo dažnumas, vertinant V3, V4 ir V5 metu. • Pirmasis vizitas, kurio metu nustatytas tiriamojo preparato vartojimo neveiksmingumas (V3, V4 arba V5). • Chirurginių intervencijų atlikimo dėl ūminio divertikulito dažnumas iki V5 ir V6. • Antimikrobinio gydymo skyrimo dėl ūminio divertikulito dažnumas iki V5 ir V6. • Gydymo ligoninėje dėl ūminio divertikulito dažnumas iki V5 ir V6. • Divertikulito komplikacijų atsiradimo dažnumas iki V5 ir V6. • Simptominių vaistinių preparatų vartojimas iki V5.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints of evaluation are included in the description of endpoints in E.5.2. |
Veiksmingumo vertinimo laikas nurodytas E.5.2 skyriuje. |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 |
dvigubai maskuotas |
double-dummy |
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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 | Yes |
E.8.2.3.1 | Comparator description |
Rifamicinas SV-MMX® 600 mg 3 k/d yra palyginamasis preparatas rifamicinui SV-MMX® 400 mg 2 k/d |
Rifamycin SV-MMX® 600 mg t.i.d. as comparator to Rifamycin SV-MMX® 400 mg b.i.d. |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 53 |
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 | No |
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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LVLS |
PPPV (paskutinio paciento paskutinis vizitas) |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 24 |