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)

September 13, 2018 updated by: Quanta Medical

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secnidazol-Ciprofloxacin
2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days
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)
Active Comparator: Amoxicillin-Clavulanic Acid
3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days
Drug: Amoxicillin-Clavulanic Acid
3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: the cure rate will be evaluated at the second visit (14 days after the inclusion visit)
the cure rate will be evaluated at the second visit (14 days after the inclusion visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quanta Medical

Collaborators

Laboratoires Iprad-Vegebom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPR_SIGMO_09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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