EUCTR2007-001950-18-BE进行中（未招募）不适用
A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN PATIENTS WITH NON-CONSTIPATING IRRITABLE BOWEL SYNDROME
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •18 to 80 years of age
- •Body Weight: (=40 kg)
- •Recurrent abdominal pain or discomfort for three or more days per month for the last three months which meets Rome III criteria for non-constipating IBS;
- •Patients on a stable diet for at least eight weeks;
- •Patients =50 years of age with a negative colonoscopy in the last five years;
- •Able and willing to comply with all protocol procedures for the planned duration of the study;
- •Able and willing to understand, sign and date an informed consent document, and authorise access to protected health information.
- •In addition, a female patient must meet the following criteria:
- •Females must be postmenopausal, surgically incapable of bearing children, or practicing a relaible method of birth control (intrauterine devices, spermicide and barrier) (Hormonal contraceptives are NOT regarded as adequate for the purposes of this trial). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must also have a negative urine pregnancy test at baseline.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Constipating IBS
- •History of untreated lactose intolerance (NB: Patients treated with diet or lactase supplements are not excluded);
- •History of colonic or major abdominal surgery (colectomy, for example);
- •Current diagnosis of major depression or psychosis;
- •Known positive stool culture for Clostridium difficile or other pathogens;
- •Any condition necessitating the administration of analgesics (except Paracetamol), probiotics, neuroleptics, antidepressants, daytime tranquilizers, prokinetics or spasmolytics medications;
- •Active thyroid disease;
- •Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling;
- •Other major physical or major psychiatric illness within the last six months that in the opinion of the investigator would affect the patient's ability to complete the trial;
- •Uncontrolled systemic disease such as diabetes;
- •Patients undergoing chemotherapy for the treatment of cancer;
- •Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used;
- •Participation in another study withing 8 weeks prior to the study
- •Unable to attend all visits required by the protocol
研究者
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