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 (DIVA)

This study has been terminated.

(difficulties to recruit patients who suffer from this pathology)

Sponsor:

Collaborator:

Laboratoires Iprad-Vegebom

Information provided by (Responsible Party):

Quanta Medical

ClinicalTrials.gov Identifier:

NCT01733966

First received: November 21, 2012

Last updated: NA

Last verified: March 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	November 21, 2012
Last Updated Date	November 21, 2012
Start Date ^ICMJE	May 2010
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 21, 2012)	to compare 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) ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief 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. The cure rate will be evaluated at the second visit (14 days after the inclusion visit)
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Diverticular Sigmoïditis
Intervention ^ICMJE	Drug: Secnidazole, ciprofloxacine 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) Drug: Amoxicillin-Clavulanic Acid 3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)
Study Arm (s)	Experimental: Secnidazol-Ciprofloxacin 2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days Intervention: Drug: Secnidazole, ciprofloxacine Active Comparator: Amoxicillin-Clavulanic Acid 3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days Intervention: Drug: Amoxicillin-Clavulanic Acid
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	100
Completion Date	March 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Biological results : CRP > 10mg/L NFS > 10G/L Neutrophil Granulocytosis > 75% Radiological results - presence to the scan :diverticul & pericolic infiltration Exclusion Criteria: 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 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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01733966
Other Study ID Numbers ^ICMJE	IPR_SIGMO_09
Has Data Monitoring Committee	Yes
Responsible Party	Quanta Medical
Study Sponsor ^ICMJE	Quanta Medical
Collaborators ^ICMJE	Laboratoires Iprad-Vegebom
Investigators ^ICMJE	Not Provided
Information Provided By	Quanta Medical
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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