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Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

NCT01222702 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-06-14

No results posted yet for this study

Summary

Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

Cadazolid

Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration

DRUG

Vancomycin

Vancomycin, provided as capsules (125 mg) for oral administration

DRUG

Placebo-matching cadazolid

Placebo of cadazolid powder for oral suspension

DRUG

Placebo-matching vancomycin

Placebo of vancomycin capsules

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Pascal Charef, DVM · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-25
Primary Completion
2012-10-16
Completion
2012-11-12
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222702 on ClinicalTrials.gov