Uncomplicated Diverticulitis
Conditions
Brief summary
The purpose of the trial is 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.
Interventions
DRUGRifamycin SV-MMX® 400 mg b.i.d.
DRUGRifamycin SV-MMX® 600 mg t.i.d.
DRUGRifamycin SV-MMX® Placebo
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent, 2. Patient is eligible for out-patient treatment, 3. Men or women between 18 and 80 years of age, 4. Diagnosis of left-sided uncomplicated diverticulitis confirmed by ultrasonography (US) and/or computed tomography (CT) according to modified Hinchey classification (stage 1a) or Hansen/Stock classification (stage I/IIa) or Ambrosetti classification (stage mild), 5. Presence of significant left lower quadrant pain during the last 24 hours before baseline, 6. CRP \> ULN and/or leucocytosis (\> ULN) at screening visit
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. Hemorrhagic diathesis, 7. Active peptic ulcer disease, 8. Abnormal hepatic function or liver cirrhosis, 9. Abnormal renal function, 10. Colorectal cancer or a history of colorectal cancer,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with treatment success at the day 10 visit | 10 days | Treatment success includes e.g.: * absence of diverticulitis related symptoms * no complications of acute diverticulitis * no hospitalisation due to acute diverticulitis |
Secondary
| Measure | Time frame |
|---|---|
| First visit with treatment success | 10 days |
| Rate of surgical intervention of acute diverticulitis | 10 days |
| Rate of hospitalisation due to acute diverticulitis | 10 days |
| Rate of occurrence of complicated diverticulitis | 10 days |
Countries
Germany
Outcome results
None listed