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
Information source: Laboratoires IPRAD
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diverticular Sigmoïditis
Intervention: Secnidazole, ciprofloxacine (Drug); Amoxicillin-Clavulanic Acid (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Laboratoires IPRAD
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).
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: cure rate after treatment period
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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 evaluation
Locations and Contacts
QuantaMedical, Rueil Malmaison 92507, France; Recruiting
Nicolas WIEL, Phone: 01 47 08 79 71, Email: n.wiel@quanta-medical.com
Marc André BIGARD, Pr, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: June 2, 2010
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