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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01733966
Other study ID # IPR_SIGMO_09
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)