EUCTR2004-004415-29-GB进行中（未招募）1 期
A Phase IIa, multi-center, multi-national, open-label, dose ranging study of the efficacy, safety, and tolerability of oral DU-176b administered once or twice daily in the treatment of adult patients undergoing total hip arthroplasty.
Daiichi Medical Research Inc0 个研究点目标入组 700 人开始时间: 2005年2月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
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
- •Patients 18 years of age or greater scheduled for elective unilateral total hip replacement surgery (including revisions).
- •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
- •Preoperative Exclusion Criteria:
- •Patients that meet any of the following criteria will not be included in the study:
- •1.Patients previously enrolled in a DU-176b study;
- •2.Patients less than 18 years of age;
- •3.Patients with known or suspected hereditary or acquired bleeding or coagulation disorder and increased risk of thromboembolic events;
- •4.Patients with an increased risk of bleeding;
- •1. Hemorrhagic stroke, or conditions predisposing to intracranial hemorrhage (e.g., previous intracranial or intra-ocular hemorrhage or non-hemorrhagic stroke within the past three months; intracranial malignancy)
- •2. Systemic bleeding, gastrointestinal bleeding, or a documented ulcer within the past three months
- •3. History of bleeding tendencies, or any significant hematologic disease that may be associated with bleeding (e.g., thrombocytopenia (<100,000/mm3) or platelet dysfunction) within the past three months
- •4. Abnormal pre-operative baseline PT, (INR), aPTT or platelet count, as defined by local laboratory controls
- •5.Uncontrolled hypertension as defined as BP> 180/100 mmHg;
- •6.Patients weighing less than 50 kg (111 lbs) or weight greater than 120 kg (265 lbs);
- •7.Patients on long-term anticoagulants-e.g. heparin (unfractionated or low molecular weight), or have received therapeutic doses of an anticoagulant within three days prior to study treatment; require ongoing treatment with a vitamin K antagonist or concomitant use of aspirin, NSAIDs with a half-life >20 hours, proton pump inhibitors or antacids;
- •8.Patients with contraindications to venography such as;
- •1.Renal dysfunction as evidenced by creatinine (defined as >1.5 mg/dl or >132 ?mol/L)
- •2.History of allergy to iodine or radiopaque dye;
- •3.Inadequate pedal veins for cannulation for venography.
- •9.Patients with a past medical history of venous thromboembolism;
- •10.Patients with impaired hepatic function, as shown by any of the following;
- •SGOT/AST ? 3 times the upper limit of the reference range
- •SGPT/ALT ? 3 times the upper limit of the reference range
- •Alkaline phosphatase ? 2 times the upper limit of the reference range
- •Abnormal prothrombin time (>1.5 times baseline control) at study entry
- •Bilirubin >2 times the upper limit of reference range;
- •11.Spinal or epidural anesthesia with traumatic puncture or catheter placement or with prolonged bleeding from the puncture site;
- •12.Patients who have received any investigational drug within 1 month prior to study entry or such treatment is planned during the study period;
- •13.Patients with any concomitant condition, including clinically relevant cardiovascular, neurologic, endocrine, metastatic or hematological malignancy; or other major systemic disease that make implementation of the protocol or interpretation of the study results difficult;
- •14.Immunocompromised patients, such as patients with HIV infection;
- •15.Patients unlikely to comply with the protocol, (e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study);
- •16.Currently receiving treatment with any other investigational drug or experimental device;
- •17.Known to be pregnant (all women of childbearing potential require a negative pregnancy test [?-HCG] within 6 weeks or less prior to surgery);
- •18.Lactating women
- •19.Failure to provide informed consent and HIPAA authorization (USA subjects only) prior to enrollment into the study.
- •20.Patients with a positive screening result for hepatitis A immunoglobulin M, he
研究者
相似试验
进行中（未招募）
1 期
An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-OTreatment- Associated Dyskinesia in Parkinson´s DiseaseEUCTR2005-000444-84-ESMerck KGaA
进行中（未招募）
不适用
An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson s disease suffering from treatment-associated dyskinesia PADDY-O .EUCTR2005-000444-84-ITMERCK S.P.A.800
进行中（未招募）
不适用
An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OEUCTR2005-000444-84-FIMerck KGaA800
进行中（未招募）
1 期
An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OTreatment-Associated Dyskinesia in Parkinson's DiseaseEUCTR2005-000444-84-GBMerck KGaA
进行中（未招募）
不适用
An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OTreatment-Associated Dyskinesia in Parkinson's DiseaseEUCTR2005-000444-84-ATMerck KGaA800