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

Diverticular Sigmoïditis Clinical Trial

— DIVA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01733966
• Other study ID #: IPR_SIGMO_09
• Status: Terminated
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2010
• Source: Quanta Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

The cure rate will be evaluated at the second visit (14 days after the inclusion visit)

Other known NCT identifiers

• NCT01136434

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Diverticular Sigmoïditis

Intervention

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)
• Amoxicillin-Clavulanic Acid
3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Quanta Medical	Laboratoires Iprad-Vegebom

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		the cure rate will be evaluated at the second visit (14 days after the inclusion visit)