E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute uncomplicated diverticulitis |
Diverticolite acuta non complicata |
|
E.1.1.1 | Medical condition in easily understood language |
Acute uncomplicated inflammation of protuberances of the bowel mucosa |
Infiammazione acuta non complicata di protuberanze della mucosa intestinale |
|
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 | 15.1 |
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 |
|
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. Rifacyn SV-MMX® 600 mg t.i.d. vs. placebo, in patients with acute uncomplicated diverticulitis |
confrontare l'efficacia di Rifamicina SV-MMX ® 400 mg bid vs Rifamicina SV-MMX ® 600 mg t.i.d. vs placebo, in pazienti affetti da diverticolite acuta non complicata |
|
E.2.2 | Secondary objectives 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 |
•Valutare il dosaggio ottimale di Rifamycin SV-MMX® per il trattamento della diverticolite acuta non complicata
•Studiare la sicurezza e la tollerabilità di Rifamycin SV-MMX® vs. placebo in termini di eventi avversi e parametri di laboratorio
|
|
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, |
1.Consenso informato firmato,
2.Uomini o donne di età compresa fra 18 e 80 anni
3.Diagnosi di diverticolite non complicata sul lato sinistro,
4.Indicazione di terapia/gestione conservativa, nessuna necessità di intervento chirurgico o procedura invasiva. |
|
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. |
1.Complicanze della diverticolite in atto (diverticolite associata ad ascesso, fistola, ostruzione o perforazione),
2.Diverticolite del lato destro,
3.Precedente intervento chirurgico al colon (ad eccezione di appendicectomia, emorroidectomia e asportazione endoscopica di polipi),
4.Malattie infiammatorie croniche intestinali (ad es. morbo di Crohn, colite ulcerosa) o malattia celiaca,
5.Presenza di malattie organiche sintomatiche del tratto gastrointestinale (ad eccezione di emorroidi non sanguinanti o ernia iatale),
6.Incapacità di tollerare l'assunzione orale.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
rate of patients with treatment success at the day 10 visit |
percentuale di pazienti con il successo del trattamento alla visita nel giorno 10 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 10 days of treatment |
dopo 10 giorni di trattamento |
|
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 |
•Tasso di successo del trattamento alla visita V3 e V4
•Prima visita con successo del trattamento (V3, V4 o V5)
•Tasso di fallimento del trattamento alla visita V3, V4 e V5
•Prima visita con fallimento del trattamento (V3, V4 o V5)
•Tasso di intervento chirurgico per diverticolite acuta fino alla visita V5 e V6
•Tasso di trattamento antimicrobico a causa di diverticolite acuta fino alla visita V5 e V6
•Tasso di ospedalizzazione per diverticolite acuta fino alla visita V5 e V6
•Tasso di insorgenza della diverticolite complicata fino alla visita V5 e V6
•Utilizzo della terapia di salvataggio fino alla visita V5
|
|
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 |
timepoints di valutazione sono inclusi nella descrizione di endpoint nella sezione E.5.2 |
|
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 |
|
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 |
Rifamycin SV-MMX® 600 mg t.i.d as comparator to Rifamycin SV-MMX® 400 mg b.i.d. |
|
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 51 |
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
|
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
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 | 8 |