EUCTR2007-001521-98-FR进行中（未招募）1 期
A Non-inferiority Comparison of 35mg Delayed-release Risedronate, Administered Once-weekly Either Before or After Breakfast, and 5mg Immediate-release Risedronate, Administered Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multicenter, Double-Blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study - Fantasia Phase III
Procter & Gamble Pharmaceuticals0 个研究点目标入组 816 人开始时间: 2007年9月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 816
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
- Female
入选标准
- •female, ambulatory and 50 years of age or older in good health as determined by the investigator be postmenopausal(>=5 years since last menses) FSH and estradiol levels are evaluated for any patient < 65 years and who has undergone hysterectomy without bilateral oophorectomy, levels must be serum FSH >=40 mIU/ml and estradiol <=20pg/ml have at least 3 evaluable lumbar spine vertebral bodies meet one of the following BMD criteria: lumbar spine BMD <0.772 g/cm2 (Hologic) or 0.694 g/cm2 (Lunar) or total hip BMD <0.637 g/cm2 (Hologic) or <0.694 g/cm2 (Lunar), i.e BMD > 2.5SD below young adult mean OR lumbar spine BMD <0.827 g/cm2 (Hologic) or 0.940 g/cm2 (Lunar) or total hip BMD <0.709 g/cm2 (Hologic) or <0.768 g/cm2 (Lunar), i.e BMD > 2.0SD below young adult mean and at least one prevalent vertebral fracture written informed 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •previous or ongoing clinically significant illness abuse of alcohol, prescription or illicit drugs any condition or disease that may interfere with evaluation of lumbar spine BMD bilateral hip prostheses hyperparathyroidism unless sugically corrected and normal serum calcium levels 12 months prior to enrollment uncontrolled hyperthyroidism or ongoing osteomalacia history of cancer in last 5 years except basal cell carcinoma and dermal squamous cell carcinoma with 6-month remission BMI >32 kg/m2 known allergy or intolerance to bisphosphonates or any of the excipients use of IV bisphosphonates within 12 months any use of following medications within 3 months of study, or use greater than 1 month 3-6 months prior to study: anabolic steroids, estrogens (except low dose), progestins, calcitonin, vit D supplements (>1200 IU per day), calcitriol, calcidiol or alfacalcidol, bisphosphonates, fluoride >=10mg daily, strontium >=50mg daily,PTH and teriperatide, glucocorticoid use as defined in the protocol and a depot injection of vit D >12,000 IU in the past 9 months abnormal clinical laboratory results, including creatinine clearance, hypocalcaemia, hypercalcaemia, TSH and serum 25-hydroxy vitamin D as defined in the protocol participation in another clinical trial 30 days prior to screening BMD <5.0SD below young adult female mean value use of any anticonvulsant within 1 month or use for more than 1 month within 6 months of study start use of proton pump inhibitors >3 times per week for >=3 weeks within 4 weeks prior to study start postive fecal occult blood testing history of inflammatory bowel disease, malabsorption or sprue
研究者
相似试验
进行中（未招募）
不适用
A Non-inferiority Comparison of 35mg Delayed-release Risedronate, Administered Once-weekly Either Before or After Breakfast, and 5mg Immediate-release Risedronate, Administered Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multicenter, Double-Blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study - Fantasia Phase IIIEUCTR2007-001521-98-EEProcter & Gamble Pharmaceuticals816
进行中（未招募）
不适用
A Non-inferiority Comparison of 35mg Delayed-release Risedronate, Administered Once-weekly Either Before or After Breakfast, and 5mg Immediate-release Risedronate, Administered Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multicenter, Double-Blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study - Fantasia Phase IIITreatment of Post-menopuasal OsteoporosisMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausalEUCTR2007-001521-98-HUProcter & Gamble Pharmaceuticals816
进行中（未招募）
不适用
A Non-inferiority Comparison of 35mg Delayed-release Risedronate, Administered Once-weekly Either Before or After Breakfast, and 5mg Immediate-release Risedronate, Administered Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multicenter, Double-Blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study - Fantasia Phase IIITreatment of Post-menopuasal OsteoporosisMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausalEUCTR2007-001521-98-PLProcter & Gamble Pharmaceuticals816
进行中（未招募）
不适用
A Non-inferiority Comparison of 35mg Delayed-release Risedronate, Administered Once-weekly Either Before or After Breakfast, and 5mg Immediate-release Risedronate, Administered Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multicenter, Double-Blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study - Fantasia Phase IIITreatment of Post-menopuasal OsteoporosisMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausalEUCTR2007-001521-98-BEProcter & Gamble Pharmaceuticals816
招募中
1 期
Comparison study of the pre emptive of the two dose of dexmedetomidine (bolus and infusion) on post operative pain, nausea and vomiting for laparoscopic cholecystectomyPain, nausea and vomiting.IRCT20101211005362N31Esfahan University of Medical Sciences90