A Phase 2 Study of the Effects of RDC-1036 Administered to Subjects With Opioid-induced Constipation During Treatment With Opioids for Chronic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration
详细描述
Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years of age
- •Body mass index (BMI) of 19 to 35 kg/m2 at screening
- •Receiving prescribed opioid medication for the management of chronic, non-cancer, pain
- •Diagnosis of opioid-induced constipation (OIC)
- •Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during the study.
排除标准
- •Pregnancy and/or currently breastfeeding
- •Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
- •Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
- •Any gastrointestinal (GI) or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars)
- •Use of medical devices such as pacemakers, infusion pumps, or insulin pumps
- •Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study
- •Participation in a clinical trial of a pharmacological agent within 30 days before screening
研究组 & 干预措施
RDC-1036 (ALKS 37)
Capsules for oral administration
干预措施: RDC-1036 (ALKS 37) (Drug)
Placebo
Capsules for oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
时间窗: 4 Weeks
Number of subjects reporting treatment-emergent adverse events (TEAEs)
时间窗: 6 Weeks
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
次要结局
- Change in rescue laxative use from pre-treatment to treatment period(4 Weeks)
- Study drug dose prior to first SBM after randomization(4 weeks)
- Scores to study-related questionnaires(6 weeks)