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:

Drug Information available for: Amoxicillin Amoxicillin sodium Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

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 (Adult, Senior)
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


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:


Colitis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Amoxicillin Ciprofloxacin Clavulanic Acids Clavulanic Acid Amoxicillin-Potassium Clavulanate Combination Secnidazole	Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Beta-Lactamase Inhibitors Antiprotozoal Agents Antiparasitic Agents

ClinicalTrials.gov processed this record on September 27, 2016

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