A Mulitcenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation in Subjects With Chronic Non-Malignant Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 460
- 主要终点
- Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period
研究概览
简要总结
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult outpatients with opioid-induced constipation and chronic non-malignant pain.
- •Taking oral, transdermal, intravenous, or subcutaneous opioids.
- •Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.
- •Exclusion Criteria
- •History of chronic constipation before the initiation of opioid therapy.
- •Other GI disorders known to affect bowel transit.
- •Women who are pregnant, breast-feeding, or plan to become pregnant.
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: placebo (Other)
2
干预措施: N-methylnaltrexone bromide (MOA-728) (Drug)
3
干预措施: N-methylnaltrexone bromide (MOA-728) (Drug)
结局指标
主要结局
Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period
时间窗: 4 weeks
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.
Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose
时间窗: up to 4 hours
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).
次要结局
- Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period(4 weeks)
- Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period(4 weeks)
- Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks(Baseline and 4 weeks)
- Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)(8 weeks)
- Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period(8 weeks)
- Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period(8 weeks)
- Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period(4 weeks)
- Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period(4 weeks)
- Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.(weeks 5-12)
- Time to the First Rescue-free Bowel Movement (RFBM) After First Dose(up to 24 hours)
- Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period(Within 1-6 hours during 4 week double-blind period)
- Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period(Within 1-6 hours during 4-week double-blind period)
- Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period(4 weeks)
- Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)(4 weeks)
- Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)(4 weeks)
- Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period(4 weeks)
- Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks(Baseline and 4 weeks)
- Change in Weekly Number of Bowel Movements During Double-blind Period(4 weeks)
- Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)(4 weeks)
- Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period(4 weeks)