Clinical Research Details

Title:

A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR 101 Taken q12h with 125 mg Vancomycin Taken q6h for 10 Days in Subjects with Clostridium Difficile-associated Diarrhea

Purpose:

The study seeks to compare the effectiveness and safety of the investigational study drug, PAR 101, with vancomycin in the treatment of clostridium difficile-associated diarrhea (CDAD).

Study Number:

109204

Number of Patients:

650

Elgibility:

Males and females over 16 years old are eligible. The patient must have the presence of CDAD at the time of enrollment, defined as diarrhea with
four or more unformed bowel movements within the 24 hours preceding enrollment. The patient also must have the presence of either toxin A or B of C.difficile in the stool.

Treatment:

Half of the research study participants will receive the research study drug. The other half of the study participants will receive vancomycin. The doctor will ask you to take a pill four times a day for ten days. Since the research study drug is taken only every 12 hours some of the pills will be a placebo.

Principal Investigator:

Stuart Johnson, M.D.

Enrollment Phone:

(708) 216-3268