Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
Primary Purpose
Uncomplicated Diverticulitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Rifamycin SV-MMX® 400 mg b.i.d.
Rifamycin SV-MMX® 600 mg t.i.d.
Rifamycin SV-MMX® Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uncomplicated Diverticulitis
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent,
- Patient is eligible for out-patient treatment,
- Men or women between 18 and 80 years of age,
- 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),
- Presence of significant left lower quadrant pain during the last 24 hours before baseline,
- CRP > ULN and/or leucocytosis (> ULN) at screening visit
Exclusion Criteria:
- Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation),
- Right-sided diverticulitis,
- Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
- Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
- Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia),
- Hemorrhagic diathesis,
- Active peptic ulcer disease,
- Abnormal hepatic function or liver cirrhosis,
- Abnormal renal function,
- Colorectal cancer or a history of colorectal cancer,
Sites / Locations
- Evangelisches Krankenhaus Kalk
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Rifamycin SV-MMX® 400 mg b.i.d.
Rifamycin SV-MMX® 600 mg t.i.d.
Rifamycin SV-MMX® Placebo
Arm Description
Rifamycin SV-MMX® 800 mg
Rifamycin SV-MMX® 1800 mg
Rifamycin SV-MMX® placebo
Outcomes
Primary Outcome Measures
Rate of patients with treatment success at the day 10 visit
Treatment success includes e.g.:
absence of diverticulitis related symptoms
no complications of acute diverticulitis
no hospitalisation due to acute diverticulitis
Secondary Outcome Measures
First visit with treatment success
Rate of surgical intervention of acute diverticulitis
Rate of hospitalisation due to acute diverticulitis
Rate of occurrence of complicated diverticulitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847664
Brief Title
Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
Official Title
A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy of Oral Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in the Treatment of Acute Uncomplicated Diverticulitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Diverticulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rifamycin SV-MMX® 400 mg b.i.d.
Arm Type
Experimental
Arm Description
Rifamycin SV-MMX® 800 mg
Arm Title
Rifamycin SV-MMX® 600 mg t.i.d.
Arm Type
Experimental
Arm Description
Rifamycin SV-MMX® 1800 mg
Arm Title
Rifamycin SV-MMX® Placebo
Arm Type
Placebo Comparator
Arm Description
Rifamycin SV-MMX® placebo
Intervention Type
Drug
Intervention Name(s)
Rifamycin SV-MMX® 400 mg b.i.d.
Intervention Type
Drug
Intervention Name(s)
Rifamycin SV-MMX® 600 mg t.i.d.
Intervention Type
Drug
Intervention Name(s)
Rifamycin SV-MMX® Placebo
Primary Outcome Measure Information:
Title
Rate of patients with treatment success at the day 10 visit
Description
Treatment success includes e.g.:
absence of diverticulitis related symptoms
no complications of acute diverticulitis
no hospitalisation due to acute diverticulitis
Time Frame
10 days
Secondary Outcome Measure Information:
Title
First visit with treatment success
Time Frame
10 days
Title
Rate of surgical intervention of acute diverticulitis
Time Frame
10 days
Title
Rate of hospitalisation due to acute diverticulitis
Time Frame
10 days
Title
Rate of occurrence of complicated diverticulitis
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent,
Patient is eligible for out-patient treatment,
Men or women between 18 and 80 years of age,
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),
Presence of significant left lower quadrant pain during the last 24 hours before baseline,
CRP > ULN and/or leucocytosis (> ULN) at screening visit
Exclusion Criteria:
Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation),
Right-sided diverticulitis,
Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia),
Hemorrhagic diathesis,
Active peptic ulcer disease,
Abnormal hepatic function or liver cirrhosis,
Abnormal renal function,
Colorectal cancer or a history of colorectal cancer,
Facility Information:
Facility Name
Evangelisches Krankenhaus Kalk
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51103
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
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