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

November 21, 2012
November 21, 2012
May 2010
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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 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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diverticular Sigmoïditis
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01733966
IPR_SIGMO_09
Yes
Quanta Medical
Quanta Medical
Laboratoires Iprad-Vegebom
Not Provided
Quanta Medical
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP