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

NCT01733966 | Terminated Phase 3 DMC

• 1 other identifier: IPR_SIGMO_09
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Diverticular Sigmoïditis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Secnidazol-Ciprofloxacin

EXPERIMENTAL

2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days

Drug: Secnidazole, ciprofloxacine

Amoxicillin-Clavulanic Acid

ACTIVE COMPARATOR

3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days

Drug: Amoxicillin-Clavulanic Acid

Interventions

Secnidazole, ciprofloxacine DRUG

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)

Secnidazol-Ciprofloxacin

Amoxicillin-Clavulanic Acid DRUG

3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)

Amoxicillin-Clavulanic Acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients treated by morphinic drug
• Patients treated by anticoagulant drug
• Pregnant or breast-feeding women
• Patients presenting allergy to active principal, to galactose
• 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

Sponsors & Collaborators

• Quanta Medical: lead
• Laboratoires Iprad-Vegebom: collaborator

MeSH Terms

Interventions

secnidazole; Ciprofloxacin; Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: May 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 17, 2018

Record last verified: 2010-03