A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment
试验速览
- 阶段
- 3 期
- 入组人数
- 56
- 试验地点
- 60
- 主要终点
- Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
研究概览
简要总结
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).
详细描述
This is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules.
This study received agreement from the FDA, under a special protocol assessment.
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, Care Provider, Investigator)
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
- •Documented evidence of active acromegaly
- •Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
- •Biochemically controlled
排除标准
- •Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label
- •Pituitary surgery within six months
- •Conventional or stereotactic pituitary radiotherapy any time in the past
- •Patients who previously participated in CH-ACM-01 or OOC-ACM-302
- •Any clinically significant uncontrolled concomitant disease
- •Symptomatic cholelithiasis
- •Pegvisomant, within 24 weeks
- •Dopamine agonists, within 12 weeks
- •Pasireotide, within 24 weeks
研究组 & 干预措施
Octreotide capsules
Octreotide capsules
干预措施: octreotide capsules (Drug)
Matching Placebo
Matching placebo capsules
干预措施: Matching placebo (Drug)
结局指标
主要结局
Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
时间窗: Week 36
Maintenance of response was defined by using the average IGF-1 level of the last 2 available assessments in the DPC period. If the average IGF-1 is ≤ 1×ULN, a patient was classified as a responder (i.e., maintained their biochemical response). If the average IGF-1 is \> 1×ULN, a patient was classified as a non-responder. Patients who discontinue study medication during the DPC period for any reason was classified as non-responders for the primary analysis, regardless of their IGF-1 values.
次要结局
- Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period(Week 36)
- Number of Patients Who Begin Rescue Treatment(Week 36)