Diverticular SigmoïditisPhase 3DIVANCT01733966
A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
A Phase 3 study testing Secnidazole, ciprofloxacine and Amoxicillin-Clavulanic Acid in people with Diverticular Sigmoïditis, run by Quanta Medical.
Trial summary
The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diverticular Sigmoïditis
- What is being tested?
- Secnidazole, ciprofloxacine and Amoxicillin-Clavulanic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Mar 2012
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Recovering of written and dated informed consent form
- Social Security medical cover
- Left Iliac Fossa (LIF) pain
- Moderate fever (>37.8°C)
- Sensitivity/defence during LIF palpation
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- Biological results :
- CRP > 10mg/L
- NFS > 10G/L
- Neutrophil Granulocytosis > 75%
- Radiological results - presence to the scan :diverticul \& pericolic infiltration
Who cannot join
- Patients treated by antibiotherapy in the last 15 days prior inclusion
- Patients treated by morphinic drug
- Patients treated by anticoagulant drug
- Pregnant or breast-feeding women
- Patients presenting allergy to active principal, to galactose
- Patients having taking part in another study in the last 3 months prior inclusion
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- Patients unable to comply with the study requirements
- Patients presenting Chronic affection inconsistent with the study
- Patients presenting high fever
- Patients presenting abdominal contracture
- Patients presenting immunosuppression
- Radiological sign of complication (abscess>3cm)
- Patients presenting Pathology inconsistent with efficacy evaluatio
About this study
Official title: A Third Phase, Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure.
The cure rate will be evaluated at the second visit (14 days after the inclusion visit)
- Conditions
- Diverticular Sigmoïditis
- Being tested
- Secnidazole, ciprofloxacine, Amoxicillin-Clavulanic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secnidazole, ciprofloxacineDrug
2g of microgranules of secnidazole. a single dose per day during 3 days.
1g of Ciprofloxacin (2 tablets of 500mg per day during 3 days)
Amoxicillin-Clavulanic AcidDrug
3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)
| Study group | Role | What they receive |
|---|---|---|
| Secnidazol-Ciprofloxacin | Experimental | 2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days Receives: Drug: Secnidazole, ciprofloxacine |
| Amoxicillin-Clavulanic Acid | Active comparator | 3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days Receives: Drug: Amoxicillin-Clavulanic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure
Measured: the cure rate will be evaluated at the second visit (14 days after the inclusion visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startMay 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: difficulties to recruit patients who suffer from this pathology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular SigmoïditisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratoires Iprad-Vegebom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733966
- Sponsor's protocol ID
- IPR_SIGMO_09
- Acronym
- DIVA
- Status last verified
- Mar 2010
- First submitted
- 21 Nov 2012
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Third Phase, Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
- ClinicalTrials.gov ID
- NCT01733966
- Acronym / sponsor ID
- DIVA / IPR_SIGMO_09
- Conditions
- Diverticular Sigmoïditis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties to recruit patients who suffer from this pathology
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Quanta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Laboratoires Iprad-Vegebom
- Study start
- May 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Nov 2012 (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 primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure.
The cure rate will be evaluated at the second visit (14 days after the inclusion visit)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secnidazol-Ciprofloxacin | Experimental | Drug: Secnidazole, ciprofloxacine2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days |
| Amoxicillin-Clavulanic Acid | Active comparator | Drug: Amoxicillin-Clavulanic Acid3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult
- Recovering of written and dated informed consent form
- Social Security medical cover
- Left Iliac Fossa (LIF) pain
- Moderate fever (>37.8°C)
Key exclusion criteria (13 listed)
- Patients treated by antibiotherapy in the last 15 days prior inclusion
- Patients treated by morphinic drug
- Patients treated by anticoagulant drug
- Pregnant or breast-feeding women
- Patients presenting allergy to active principal, to galactose
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 |
|---|---|---|
| Secnidazole, ciprofloxacine2g of microgranules of secnidazole. a single dose per day during 3 days. 1g of Ciprofloxacin (2 tablets of 500mg per day during 3 days) | Drug | Secnidazol-Ciprofloxacin |
| Amoxicillin-Clavulanic Acid3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days) | Drug | Amoxicillin-Clavulanic Acid |
Primary outcome
comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure
Time frame: the cure rate will be evaluated at the second visit (14 days after the inclusion visit)
Results and safety
The study was stopped early (reason given: difficulties to recruit patients who suffer from this pathology). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secnidazole, ciprofloxacine and Amoxicillin-Clavulanic Acid in people with Diverticular Sigmoïditis, run by Quanta Medical.
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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: difficulties to recruit patients who suffer from this pathology). Results are not available in the source record.
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?
comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure (time frame: the cure rate will be evaluated at the second visit (14 days after the inclusion visit)). 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 17 Sep 2018.