EUCTR2006-004291-12-IT进行中（未招募）不适用
'' 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
OPTIMER PHARMACEUTICALS INC0 个研究点目标入组 664 人开始时间: 2008年1月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 664
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
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, randomised study of PAR-101 vs vancomycin in CDADClostridium difficile associated diarrhoea (CDAD)MedDRA version: 8.1 Level: LLT Classification code 10012748 Term: Diarrhoea, Clostridium difficileEUCTR2006-004291-12-BEOptimer Pharmaceuticals Inc.664
进行中（未招募）
不适用
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, randomised study of PAR-101 vs vancomycin in CDADClostridium difficile associated diarrhoea (CDAD)MedDRA version: 8.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileEUCTR2006-004291-12-SEOptimer Pharmaceuticals, Inc.664
进行中（未招募）
不适用
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, randomised study of PAR-101 vs vancomycin in CDADClostridium difficile associated diarrhoea (CDAD)MedDRA version: 8.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileEUCTR2006-004291-12-DEOptimer Pharmaceuticals, Inc.664
进行中（未招募）
1 期
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, randomised study of PAR-101 vs vancomycin in CDADClostridium difficile associated diarrhoea (CDAD)MedDRA version: 8.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileEUCTR2006-004291-12-GBOptimer Pharmaceuticals, Inc.664
进行中（未招募）
不适用
A multi-national, multi-center, double blind, placebo-controlled, parallel group, fixed dose efficacy and safety study of SR58611A 350 mg twice daily vs. placebo in adults with Major Depressive Disorder on concomitant treatment with escitalopram 10 mg/d - ALBERIOMajor Depressive DisorderEUCTR2006-004146-16-EEsanofi-aventis recherche & développement500