Uncomplicated DiverticulitisPhase 2NCT01847664
Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
A Phase 2 study testing Rifamycin SV-MMX® 400 mg b.i.d. and Rifamycin SV-MMX® 600 mg t.i.d. in people with Uncomplicated Diverticulitis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uncomplicated Diverticulitis
- What is being tested?
- Rifamycin SV-MMX® 400 mg b.i.d. and Rifamycin SV-MMX® 600 mg t.i.d.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- Active peptic ulcer disease,
- Abnormal hepatic function or liver cirrhosis,
- Abnormal renal function,
- Colorectal cancer or a history of colorectal cancer,
Trial locations and contacts
1 site in 1 country.
Germany1 site
Evangelisches Krankenhaus Kalk
Cologne, North Rhine-Westphalia, 51103
About this study
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
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.
- Conditions
- Uncomplicated Diverticulitis
- Being tested
- Rifamycin SV-MMX® 400 mg b.i.d., Rifamycin SV-MMX® 600 mg t.i.d., Rifamycin SV-MMX® Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifamycin SV-MMX® 400 mg b.i.d.Drug
Rifamycin SV-MMX® 600 mg t.i.d.Drug
Rifamycin SV-MMX® PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Rifamycin SV-MMX® 400 mg b.i.d. | Experimental | Rifamycin SV-MMX® 800 mg Receives: Drug: Rifamycin SV-MMX® 400 mg b.i.d. |
| Rifamycin SV-MMX® 600 mg t.i.d. | Experimental | Rifamycin SV-MMX® 1800 mg Receives: Drug: Rifamycin SV-MMX® 600 mg t.i.d. |
| Rifamycin SV-MMX® Placebo | Placebo comparator | Rifamycin SV-MMX® placebo Receives: Drug: Rifamycin SV-MMX® Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Secondary outcomes (4)
First visit with treatment success
Measured: 10 days
Rate of surgical intervention of acute diverticulitis
Measured: 10 days
Rate of hospitalisation due to acute diverticulitis
Measured: 10 days
Rate of occurrence of complicated diverticulitis
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847664
- Sponsor's protocol ID
- RIT-4/DIV
- Status last verified
- Jul 2017
- First submitted
- 26 Apr 2013
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01847664
- Acronym / sponsor ID
- RIT-4/DIV
- Conditions
- Uncomplicated Diverticulitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rifamycin SV-MMX® 400 mg b.i.d. | Experimental | Drug: Rifamycin SV-MMX® 400 mg b.i.d.Rifamycin SV-MMX® 800 mg |
| Rifamycin SV-MMX® 600 mg t.i.d. | Experimental | Drug: Rifamycin SV-MMX® 600 mg t.i.d.Rifamycin SV-MMX® 1800 mg |
| Rifamycin SV-MMX® Placebo | Placebo comparator | Drug: Rifamycin SV-MMX® PlaceboRifamycin SV-MMX® placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (10 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifamycin SV-MMX® 400 mg b.i.d. | Drug | Rifamycin SV-MMX® 400 mg b.i.d. |
| Rifamycin SV-MMX® 600 mg t.i.d. | Drug | Rifamycin SV-MMX® 600 mg t.i.d. |
| Rifamycin SV-MMX® Placebo | Drug | Rifamycin SV-MMX® Placebo |
Primary outcome
Rate of patients with treatment success at the day 10 visit
Time frame: 10 days
Treatment success includes e.g.: * absence of diverticulitis related symptoms * no complications of acute diverticulitis * no hospitalisation due to acute diverticulitis
4 secondary outcomes
First visit with treatment success
Time frame: 10 days
Rate of surgical intervention of acute diverticulitis
Time frame: 10 days
Rate of hospitalisation due to acute diverticulitis
Time frame: 10 days
Rate of occurrence of complicated diverticulitis
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifamycin SV-MMX® 400 mg b.i.d. and Rifamycin SV-MMX® 600 mg t.i.d. in people with Uncomplicated Diverticulitis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with treatment success at the day 10 visit (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.