'' A multi-national, multi-centre, double-blind,randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated Diarrhea'' - A double-blind, randomized study of PAR-101vs vancomycin in CDAD

• Conditions: Patients 16 years old or older who have CDAD as defined by: -Diarrhoea:is defined as a change in bowel habits, with >3 unformed bowel movements in the 24 hours prior to randomization, -Presence of either toxin A or B of C.Difficile in the stool within 48 hours of randomization (for metronidazole failures) or 96 hours of randomization (for subjects with ≤ 24 hours pretreatment with C. difficile therapy).; MedDRA version: 14.1Level: PTClassification code 10012742Term: Diarrhoea infectiousSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2006-004291-12-IT
• Lead Sponsor: OPTIMER PHARMACEUTICALS INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-07
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 664

Inclusion Criteria

1. Male or female in/outpatients 16 years old or older who have CDAD as defined by: -Diarrhoea:is defined as a change in bowel habits, with >3 unformed bowel movements in the 24 hours prior to randomization, -Presence of either toxin A or B of C.Difficile in the stool within 48 hours of randomization (for metronidazole failures) or 96 hours of randomization (for subjects with ≤ 24 hours pretreatment with C. difficile therapy). 2. Femalesubjects of childbearing potential must be using an adequate and reliable method of contraception (eg. barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). females who are postmenopausal must have been postmenopausal at least 1 year. Subjects (both male and female)must agree to avoid contraception during treatment and for four weeks following the end of study treatments. 3. All subjects will be required to sign an Informed Consent form. 4. Opiates will be permitted as long as the subjects is on a stable dose at the time of randomization and is expected to mantein this dose during the treatment period: PRN opiate is permitted as long as the total daily dose is not changed during the treatment period. 5. Subjects who have failed at least a full 3-day course of metronidazole but continue to meet the definition of diarrhea without any significant clinical emprovement and remain toxin positive maybe enrolled in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Life threatening or fulminant CDAD (WBC>30x109/L; temperature >40C; or evidence of hypotension [systolic blood pressure less than 90 mmHg, and septic shock, peritoneal sign or significant dehydration.) 2. toxic megacolon. 3. Previous exposure to PAR-101/OPT-80. 4. Females who are pregnant or breastfeeding. 5.Likelihood of death within 72 hours from any cause. 6. Concurrent use of: oral vancomycin, metronidazole, oral bacitracin, fusidic acid, rifaximin, nitazoxanide, or related drugs. If the investigator feels the clinical imperative to begin treatment before knowing the laboratory result for stool toxin, up to 4 doses but no more than 24 hours of treatment with metronidazole and/or vancomycin will be allowed. While such pretreated subjects may be enrolled (i.e. no more than 24 hours of previous therapy), it is preferred that subjects who have not received prior CDAD treatment on this admission. 7. The anticipated need to continue other antibacterials for a period exceeding seven days from study start. 8. Subjects who in the opinion of the investigator require other drugs to control diarrhea (e.g. loperamide) or which could affect peristalsis. 9.Unable or unwilling to comply with sudy protocol, including ingesting capsules, having blood drawn, and providing stool samples as scheduled. 10. Participation in other clinical research studies utilising an investigational agent within one month prior to screening or within five half lives of the investigational agent, whichever is longer. 11. History of ulcerative colitis or Crohn's disease. 12. multiple occurrences (defined as more than one prior occurrence) of CDAD within the past three months. Subjects presenting with the first recurrence within the three months may be enrolled.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate that the cure rate of CDAD following treatment with PAR-101/OPT-80 is no worse than that following treatment with vancomycin. Evaluate the safety and tolerability of PAR-101/OPT-80 in subjects with CDAD.;Secondary Objective: Demonstrate that the rate of recurrence of CDAD following treatment with PAR-101/OPT 80 is no worse than that following treatment with vancomycin.;Primary end point(s): Demonstrate that the cure rate of CDADfollowing treatment with PAR-101 is no worse than that following treatment with vancomycin.