NCT01367574已完成2 期
A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of subjects who have a bowel movement within four hours of dosing
研究概览
简要总结
This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
- •Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
- •Must have constipation
- •Must be 18 yrs or older
排除标准
- •Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
- •Patients who received any experimental drug in the last 30 days
- •Patients with active peritoneal cancer (ovarian, etc.)
- •Patients with active diverticulitis or diverticulosis
研究组 & 干预措施
Arm 1
Experimental
干预措施: SC MNTX (Drug)
Arm 2
Experimental
干预措施: SC MNTX (Drug)
Arm 3
Experimental
干预措施: SC MNTX (Drug)
结局指标
主要结局
Number of subjects who have a bowel movement within four hours of dosing
时间窗: Up to 4 weeks
To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.
次要结局
- Number of subject with Adverse Events(Up to 4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic DermatitisDermatitis, AtopicNCT05999799GlaxoSmithKline161
终止
2 期
Methylprednisolone N Acetylcysteine in Hepatic ResectionsIschemic Reperfusion InjuryLiver TumourHepatic, Postoperative InsufficiencyNCT01726465Istituto Clinico Humanitas50
终止
2 期
Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisNCT05237284Sanofi305
已完成
2 期
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb SpasticityUpper Limb SpasticityNCT03821402Revance Therapeutics, Inc.83
已完成
2 期
Parallel Arm Trial of AD109 and AD504 In Patients With OSAOSA - Obstructive Sleep ApneaNCT05071612Apnimed294