ACTRN12622001319763暂停3 期
A multi-site, parallel-arm, randomised, double blind, placebo-controlled study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- Emyria Ltd
- 入组人数
- 300
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 70 Years（—）
- 性别
- All
入选标准
- •Chronic pain (defined as pain that has persisted for at least 3 months prior to date of consent)
- •- Self-reported at least mild psychological distress symptoms as measured by a baseline DASS-21 anxiety symptom score 8 or more
- •- If taking pain medications at the time of screening dose must be stable for at least one month prior to study screening
- •- Women of childbearing potential and men with sexual partners of childbearing potential must confirm the use of at least one acceptable form of contraception to be used throughout study participation.
排除标准
- •- Current diagnosis of mental health disorder as defined by DSM-5
- •- Currently taking or has taken any psychotropic medications for treatment of mental health illness for one month prior to screening
- •- Current suicidality or self-harm ideation
- •- Pregnant females
- •- History of drug or alcohol abuse within 6 months of screening as per investigator judgement or a positive urine drug screen for THC
- •- Currently taking or has taken any cannabinoid products within 30 days of trial treatment.
研究者
相似试验
已完成
不适用
uSing Meditation App to Reduce ED occupational sTress - SMART trialoccupational stressburnoutMental Health - Other mental health disordersACTRN12619001175167niversity of Queensland148
终止
3 期
Effect of opioids on outcomes of pulmonary rehabilitatioChronic obstructive pulmonary diseaseRespiratory - Chronic obstructive pulmonary diseasePhysical Medicine / Rehabilitation - PhysiotherapyACTRN12615000121561Flinders University260
已完成
3 期
A randomised double-blind multi-site parallel arm controlled trial to assess relief of refractory breathlessness comparing fixed doses of morphine and placebo.Refractory breathlessness.Respiratory - Other respiratory disorders / diseasesACTRN12609000806268Flinders University236
招募中
3 期
A Clinical trial to evaluate the efficacy, safety and tolerability of FDC of Dapagliflozin 10mg and Telmisartan 80mg in patients with chronic kidney diseaseCTRI/2024/04/065084ERIS LIFESCIENCES LIMITED
Unknown
3 期
A phase 3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients with metastatic colorectal cancerCTRI/2015/10/006331AB Science2