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
  Purpose

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)


Condition Intervention Phase
Diverticular Sigmoïditis
Drug: Secnidazole, ciprofloxacine
Drug: Amoxicillin-Clavulanic Acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Quanta Medical:

Primary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 evaluatio
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Quanta Medical
ClinicalTrials.gov Identifier: NCT01733966     History of Changes
Obsolete Identifiers: NCT01136434
Other Study ID Numbers: IPR_SIGMO_09
Study First Received: November 21, 2012
Last Updated: November 21, 2012
Health Authority: France : AFSSAPS. (Agence Francaise de Sécurité Sanitaire des Produits de Santé).

Additional relevant MeSH terms:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Ciprofloxacin
Secnidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014