跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2010-020484-20-DE
EUCTR2010-020484-20-DE进行中（未招募）不适用

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO ASSESS THE SAFETY AND EFFICACY OF VP 20621 FOR PREVENTION OF RECURRENCE OF CLOSTRIDIUM DIFFICILE INFECTION (CDI) IN ADULTS PREVIOUSLY TREATED FOR CDI

ViroPharma Incorporated0 个研究点目标入组 174 人开始时间: 2011年5月6日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
174
研究概览入排标准研究者记录与标识符相似试验

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

  • •To be eligible for this protocol, subjects must:
  • •1.Be =18 years of age.
  • •2.Have been diagnosed with a qualifying episode of CDI, defined as ALL of the following:
  • •=3 unformed (loose or watery) stools within a 24-hour period.
  • •A documented positive C. difficile toxin assay (enzyme immunoassay [EIA] or cellular cytotoxicity assay) or DNA PCR assay for toxigenic C. difficile from a stool sample collected while the subject was symptomatic; or documented colonic pseudomembranes on endoscopy.
  • •The diarrhea must have been considered unlikely to have another etiology.
  • •3.Have a qualifying episode of CDI with symptoms that started within 28 days (inclusive) prior to the day of randomization.
  • •4.Have a qualifying episode of CDI that is either a primary episode or a first recurrence of a prior episode.
  • •Primary episode: the subject had no episodes of CDI (other than the qualifying episode) within 6 months before the day of randomization.
  • •First recurrence: the subject had only one episode of CDI (other than the qualifying episode) within 6 months before the day of randomization; the prior episode of CDI was diagnosed within 8 weeks before the onset of symptoms of the qualifying episode of CDI, and subsequently resolved (in the opinion of the investigator) at least 2 days before the onset of the qualifying episode of CDI.
  • •5.At the time of randomization, have been treated for the qualifying episode of CDI with a single course of metronidazole or oral vancomycin for a total of at least 10 and no more than 21 days. [The treatment may have switched between metronidazole (oral or intravenous) and oral vancomycin, provided that the total treatment course was of 10 21 days duration (inclusive).]
  • •6.Have recovered from the qualifying episode of CDI, defined as ALL of the following:
  • •<3 unformed (loose or watery) stools per day for at least 2 consecutive days prior to and continuing to the time of randomization.
  • •Abdominal discomfort must be absent or only mild for at least 2 consecutive days prior to and continuing to the time of randomization.
  • •7.Be randomized such that the first dose of study drug is administered 1 calendar day (or at most 2 calendar days) after the end of the course of metronidazole or oral vancomycin.
  • •8.Be willing and able to follow study procedures (e.g., study visits, provide stool samples according to the study schedule, and reliably record information in a study diary), or have a caregiver who can ensure that study procedures are followed.
  • •9.If female, be post-menopausal (cessation of menses greater than or equal to 1 year), surgically sterile or following an acceptable non-hormonal method of birth control such as abstinence, intrauterine device, or barrier control for at least 1 complete menstrual cycle before the screening visit, or using estrogen/progestin containing products for at least 3 months before the screening visit through discharge from the study.
  • •10.Have reliable access to telephone service to allow for contact with study personnel.
  • •11.Have reliable access to a refrigerator for storage of study drug.
  • •12.Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed (or have a legally authorized representative provide such consent).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 80
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of sub

排除标准

  • •To be eligible for this protocol, subjects must not:
  • •1.Have had more than 1 episode of CDI (other than the qualifying episode) within 6 months before the day of randomization.
  • •2.Have received any of the following for treatment of the qualifying episode of CDI:
  • •Any anti-microbial therapy other than metronidazole or oral vancomycin
  • •Any immunotherapy (e.g., intravenous immunoglobulin)
  • •Any toxin-binding therapy (e.g., cholestyramine [Questran], colestipol [Colestid], or colesevelam [Welchol])
  • •3.Have any of the following GI disorders:
  • •diagnosis of inflammatory bowel disease
  • •diagnosis of celiac disease
  • •active irritable bowel syndrome (associated with symptoms within 6 months before the day of randomization)
  • •active gastroparesis (associated with symptoms within 6 months before the day of randomization)
  • •toxic megacolon during the qualifying episode of CDI
  • •GI surgery within 6 weeks before the day of randomization
  • •4.Have received loperamide (e.g., Imodium), diphenoxylate (e.g., Lomotil), or opium tincture (including laudanum and paregoric) within 3 days before the day of randomization.
  • •5.Have an acute febrile illness (fever >38?C [100.4?F]) on Day 1 prior to the first dose of study drug.
  • •6.Be planning to receive any oral or parenteral (e.g., intravenous, intramuscular, or intraperitoneal) antibacterial therapy after randomization.
  • •7.Have any contraindication to oral/enteral therapy (e.g., severe nausea/vomiting or ileus).
  • •8.Have an absolute neutrophil count <1000/mm3 [1.0 x 109/L] at screening.
  • •9.Have a known immunodeficiency disorder, including but not limited to:
  • •HIV infection
  • •receiving treatment with systemic corticosteroids at a dosage equivalent to =10 mg/day of prednisone
  • •receiving myelosuppressive cancer chemotherapy
  • •10.If outpatient at any time during the study, have household contacts (i.e., those who also occupy the subject’s particular housing unit as their residence during this time) who are <2 years of age or who have an immunodeficiency disorder (including but not limited to the conditions listed in Exclusion criterion #9).
  • •11.Require or have an anticipated need for mechanical ventilation or vasopressors for hemodynamic support during the study.
  • •12.Be pregnant or breastfeeding.
  • •13.Have participated in an active dosing phase of any other investigational (unapproved) drug evaluation within 30 days prior to the screening visit.
  • •14.Have any clinically significant medical or surgical condition that in the investigator’s or sponsor’s opinion could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject.
  • •15.Have a known hypersensitivity to any ingredient in the study formulation.

研究者

相似试验

进行中（未招募）
1 期
A clinical trial to evaluate whether a potential new drug is an effective and safe way to make damaged kidneys work better in patients with type II diabetes
EUCTR2010-021358-20-GBPfizer Inc. 235 east 42nd Street, New York, NY 10017256
进行中（未招募）
1 期
A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)Ankylosing Spondylitis (AS)MedDRA version: 17.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
EUCTR2011-005689-39-SKPfizer Inc. 235 East 42nd Street, New York, 10017208
进行中（未招募）
1 期
Evaluation of EDP-938 in subjects aged 28 days to 36 months infected with respiratory syncytial virus (RSV)
EUCTR2020-001966-13-PLEnanta Pharmaceuticals, Inc.90
未知
不适用
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ADMINISTRATION OF A CHEMOKINE CCR2/5 RECEPTOR ANTAGONIST (PF-04634817) IN ADULTS WITH TYPE 2 DIABETESAND OVERT NEPHROPATHY-E112 Non-insulin-dependent diabetes mellitus, with renal complicationsNon-insulin-dependent diabetes mellitus, with renal complicationsE112
PER-039-13PFIZER S.A.,10
进行中（未招募）
1 期
STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 OR STAGE 4 LIVER FIBROSIS
EUCTR2018-004431-79-GBCelgene Corporation300