A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered Orally for 8 Weeks to Adult Outpatients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 77
- 主要终点
- Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week)
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months.
This study included up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. This 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of 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
- •Patient has chronic non-cancer pain that has been present for a minimum of 3 months
- •Patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks
- •Patient meets protocol criteria for Opioid-Induced Constipation (OIC): < 3 spontaneous bowel movements (SBMs) per week and reports one of the following symptoms for at least 4 weeks:
- •Straining during > 25% of BMs
- •Lumpy or hard stools during > 25% of BMs
- •Sensation of incomplete evacuation during > 25% of BMs
- •Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines
- •Patient has successfully completed protocol procedures (with no clinically significant findings)
- •Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting
- •Patient has a total of < 6 SBMs in IVRS during the 14 days before and up to the time of Randomization
- •Patient has adequate relief and well-controlled pain with current dose of opioid
排除标准
- •Patient has been using opioids for abdominal pain
- •Patient has symptoms of or been diagnosed with chronic constipation or chronic idiopathic constipation prior to initiation of opioid treatment
- •Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) prior to initiation of opioid treatment
- •Patient has a history of loose or watery stools for > 25% of BMs during the 3 months before the Screening in the absence of laxatives, suppositories, or enemas
- •Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
- •Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
研究组 & 干预措施
Linaclotide 145 micrograms
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
干预措施: Linaclotide 145 micrograms (Drug)
Linaclotide 290 micrograms
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
干预措施: Linaclotide 290 micrograms (Drug)
Placebo
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week)
时间窗: Baseline (Week 0) to Week 8
Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.
次要结局
- Time to First SBM After the First Dose of Investigational Product(Baseline (Day 0) up to 8 weeks)
- Percentage of Participants Meeting 6/8 Week Spontaneous Bowel Movement (SBM) 3 + 1 Responder Criteria(8-week treatment period)
- Change From Baseline in 8-Week Stool Consistency(Baseline (Week 0) to Week 8)
- Change From Baseline in 8-Week Straining(Baseline (Week 0) to Week 8)
- Change From Baseline in 8-Week Abdominal Bloating(Baseline (Week 0) to Week 8)