NCT01222702

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

A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid (ACT-179811) in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-01-25
• Primary completion: 2012-10-16
• Completion: 2012-11-12
• First posted: 2010-10-18
• Last updated: 2017-06-14

Locations

23 sites across 6 countries: United States, Canada, Germany, Italy, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study