ACTRN12615000987561尚未招募2 期
A Randomised, Double-Blind, Parallel-Group, Placebo Controlled Phase II Study to Assess the Clinical Benefit of 3 Doses of PAX-1 as Adjunctive Treatment for Persistent Cancer Pain
Bio And Gene Pty Ltd0 个研究点目标入组 120 人开始时间: 2015年9月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Participants with moderate or severe, persistent cancer-related pain who are receiving WHO Step 3 cancer pain treatment. The type of cancer is non specific and the patient should be in palliative care.
- •2) Pain generator (source of pain) must be primarily due to underlying cancer or cancer treatment
- •3) Pain intensity must be moderate or severe defined by an average daily pain score of >= 4 achieved over a minimum of 2 days within the 7 days preceding randomisation.
- •4) Australian-modified Karnofsky Performance Scale Score of >= 50
- •5) Ability to complete study questionnaires and provide written informed consent
- •6) Adequate haematological, hepatic and renal functions required
- •7) Participant is able to take medication orally
- •8) Women of childbearing potential must have a negative pregnancy test and agree to adequate birth control if conception is possible during the study and up to 6 months after the discontinuation of study medications; and males must agree to adequate birth control during the study and up to 6 months after the discontinuation of study medication.
排除标准
- •1)Unstable pain at study Visit 1 (screening visit) and Visit 2 (randomisation visit)
- •2)Use of prohibited adjuvant pain treatment (including interventional pain procedures) in the 7 days preceding Visit 1 or plan to use these medications/procedures during the study,
- •3) Participants without a functional digestive system. Participants with percutaneous endoscopic gastrostomy (PEG), colectomy, colostomy, and conditions such as irritable bowel syndrome
- •4)Antitumour treatments (chemotherapy and targeted therapies) within 2 weeks prior to randomisation or planned to take place during the study.
- •5)HIV or AIDS, autoimmune disorders (including Crohn's Disease and Inflammatory Bowel Disease) or history of organ transplantation who require immunosuppressive therapy.
- •6)Has had certain other recent treatment e.g. extended field radiotherapy or limited field radiotherapy within 4 weeks prior to randomisation, or radiotherapy planned to take place during the study for the purpose of relieving pain
- •7)Planned major surgery during the study
- •8)Is a Lactating or pregnant female
- •9)Participants who required regular medications for a chronic pain syndrome prior to their diagnosis of cancer
- •10)Certain cardiac medical conditions
- •11)Has received any investigational product in the past 4 weeks prior to starting the study
- •12)known or suspected hypersensitivities, allergies to sodium meta-arsenite, related compounds or any of the excipients of the study drug (calcium phosphate dibasic anhydrous, silicified microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, and sodium stearyl fumarate)
- •13)Has any unresolved toxicity to <= CTCAE grade 2 attributed to any prior therapies
- •14) Taking an anti-platelet and anticoagulant combination or two or more anti-platelet agents.
- •15) Taking any medication containing arsenic trioxide.
研究者
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