NCT00911261已完成3 期
An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain
Endo Pharmaceuticals0 个研究点目标入组 223 人开始时间: 2003年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 主要终点
- Tolerability
研究概览
简要总结
The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.
详细描述
The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •≥ 18 years of age or older, with moderate to severe chronic malignant and/or neuropathic pain of at least 3 months duration and either:
- •have an initial pain intensity score of greater than 4 on a 10-point scale using BPI Question 5, if sub-optimally responding to their current analgesic regimen, or
- •have intolerable side effects to one or more components of their current opioid-containing analgesic regimen.
- •Currently receive a stable (at least 2 weeks duration) analgesic regimen
- •If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method).
- •Understand written and spoken English
- •Have been informed of the nature of the study and provided written informed consent
- •Additional Inclusion Criteria for Cancer Patients Only:
- •Have a life expectancy of at least 12 months
- •Additional Inclusion Criteria for Neuropathic Patients Only:
- •Have a diagnosis of:
- •post-herpetic neuralgia (PHN)
- •diabetic neuropathy (DN)
- •complex regional pain syndrome (CRPS)
- •HIV neuropathy
- •idiopathic sensory neuropathy
- •traumatic peripheral neuropathy
- •central neuropathic pain condition (spinal cord injury, post-stroke pain), OR
- •other peripheral neuropathy (upon mutual agreement of the sponsor and investigator).
排除标准
- •Have a positive pregnancy test (females only)
- •Have a history of or active asthma or emphysema
- •Have clinically significant hepatic impairment
- •Have a history of alcohol or substance abuse within the last 3 years
- •Have a history of opioid abuse within 6 months prior to study entry
- •Have a known allergy or significant reaction to opioids, including codeine
- •Have a known oxymorphone sensitivity or allergy
- •Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
研究组 & 干预措施
Single Arm
Experimental
干预措施: Oxymorphone Extended Release (Drug)
结局指标
主要结局
Tolerability
时间窗: Throughout the study
次要结局
- Average daily pain intensity (Question 5 of BPI)(Week 1-4, Month 12)
- Question 3, 4, 5, 6, 8, and 9 of BPI questionnaire(Week 1-4, Month 12)
- Average daily dose of oxymorphone ER(Daily)
- Average daily dose of rescue medication(Daily)
- Total daily dose of oxymorphone ER and rescue medication(Daily)
- Time to stabilization(Month 12)
- Patient/investigator global assessment of pain relief(Month 12)
- Treatment Satisfaction(Month 12)
研究者
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