NCT00378937已完成4 期
An Open, Randomized, Parallel Group Study in Patients With Cancer Pain, To Compare a Two-Step Analgesic Ladder (Non-Opioid to Oxycodone) With Conventional Management Using A Three-Step Approach
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Percentage of time in assessment periods 1 and 2 (i.e., first 4 weeks) with a Box-Scale (BS)-11 pain score of ≤ 4 (i.e., mild pain)
研究概览
简要总结
RATIONALE: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It is not yet known whether oxycodone works better and is more cost effective than standard therapy in treating patients with cancer pain.
PURPOSE: This randomized phase IV trial is studying oxycodone to see how well it works compared with standard pain therapy in treating patients with cancer pain and if it is more cost effective than standard pain therapy.
详细描述
OBJECTIVES:
Primary
- Compare overall pain management in patients with cancer-related pain treated with oxycodone hydrochloride vs standard three-step analgesic therapy.
- Compare the health economics of these regimens in these patients.
Secondary
- Explore the factors that inform patients' decisions about commencing opioid analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of cancer
- •Requires regular step-2 analgesia for the management of cancer-related pain
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Must be able to take oral medication
- •Must be willing and able to complete a daily patient assessment booklet (PAB)
- •No history of the following conditions:
- •Depression
- •Personality disorders that may lead to self-harm
- •Admission to the hospital for psychiatric reasons
- •Any other psychological disorder that, in the opinion of the investigator, would preclude study treatment
- •Not at risk of additional CNS depressant effects due to study drugs
- •No known history of alcohol or drug abuse or, in the opinion of the investigator, tendency towards drug abuse or addiction
- •No current abuse of alcohol or drugs
- •No known sensitivity to oxycodone hydrochloride or other opioids
- •No history of a specific or allergic reaction to study drugs
- •No contraindications as a result of adverse drug reaction or drug interactions of oxycodone or other opioid drugs
- •No other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation
- •PRIOR CONCURRENT THERAPY:
- •More than 30 days since prior and no concurrent chemotherapy or radiotherapy
- •At least 2 weeks since prior regular (i.e., 4 times per day) step-2 analgesics
- •More than 3 months since prior regular use of opioids, defined as having a regular prescription of an opioid medication
- •Not planning to undergo cancer-related surgery
- •No other concurrent opioid-based medication other than oxycodone hydrochloride capsules as escape medication (arm II)
- •No concurrent participation in another clinical trial involving a new chemical entity
排除标准
- 未提供
结局指标
主要结局
Percentage of time in assessment periods 1 and 2 (i.e., first 4 weeks) with a Box-Scale (BS)-11 pain score of ≤ 4 (i.e., mild pain)
次要结局
- Percentage of time in assessment periods 3 and 4 with a BS-11 pain score of ≤ 4
- Mean BS-11 pain scores
- Time to reach stable pain control
- Mean escape medication use
- Quality of sleep
- Global assessment of pain relief with study drugs
- Mean pain intensity, pain interference, and pain relief scores as measured by the Brief Pain Inventory
- Overall number of phone calls, home visits by a nurse, home visits by a doctor, and unscheduled visits to a healthcare provider, related to pain control or analgesic medication during study treatment
研究者
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终止
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