A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 主要终点
- Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.
详细描述
This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 600 participants (300 participants per treatment group) with OIC will be randomized at approximately 75 study centers to receive either oral 0.25 mg CB-5945 BID or oral matching placebo BID for the 12-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for clinical response for duration of their study participation. All participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. The clinical study report for this study includes pooled results for studies 5945-OIC-12-02 (NCT01901302) 5945-OIC-12-03 (NCT01901328), and 5945-OIC-12-04 (NCT01901341).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily dose (METDD) for chronic non-cancer pain
- •Has constipation that is caused by the chronic use of opioids
- •Is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from Screening until the last study assessment
排除标准
- •Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example [e.g.], obstruction) or contribute to bowel dysfunction
- •Has evidence of intestinal obstruction
- •Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening
- •Has an active malignancy of any type (participants with a history of successfully treated malignancy >5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
- •Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
- •Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
研究组 & 干预措施
CB-5945
0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period
干预措施: CB-5945 (Drug)
Placebo
Placebo BID for a 12-week treatment period
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks
时间窗: 12 weeks
A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. A Complete SBM (CSBM) Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).
次要结局
- Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks(Baseline, 12 weeks)
- Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks(12 weeks)