NCT00911287已完成3 期
An Open-Label Effectiveness and Safety Study of Oxymorphone Extended Release in Opioid-Naive Patients With Chronic Pain.
Endo Pharmaceuticals0 个研究点目标入组 129 人开始时间: 2003年6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
- 129
- 主要终点
- Tolerability.
研究概览
简要总结
The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.
详细描述
The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.
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
- •Currently receive a stable non-opioid analgesic regimen
- •Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
- •If female, must be practicing abstinence or using a medically acceptable form of contraception
- •Understand written and spoken English
- •Have been informed of the nature of the study and provided written informed consent.
排除标准
- •Positive pregnancy test (females only)
- •History of or active asthma or emphysema
- •Clinically significant hepatic impairment
- •Received any of the following medications within 48 hours prior to dosing:
- •Dextromethorphan-containing medications (over-the-counter [OTC] cough and cold preparations, such as Vicks Formula 44)
- •St. John's Wort >1000 mg/day
- •Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing
- •Are not stabilized on the following medications for at least 4 weeks prior to dosing:
- •Tricyclic antidepressant drugs
- •Serotonin reuptake inhibitors
- •Amphetamines used for attention-deficit/hyperactivity disorder (ADHD)
- •History of alcohol or substance abuse within the last 3 years
- •History of opioid abuse within 6 months prior to study entry
- •Have a known oxymorphone sensitivity or allergy
- •Have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient
- •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
- •Have a known allergy or significant reaction to opioids
- •Have been a participant in a previous oxymorphone clinical trial
- •Have a history of seizure (Patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).
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: Entire study duration, including follow-up period.
次要结局
- Average daily pain intensity (Question 5 of the Brief Pain Inventory [BPI] questionnaire) during the titration/stabilization period(Week 1-4, Month 1-6)
- Questions 3, 4, 5, 6, 8, and 9 of the BPI questionnaire(Week 1-4, Month 1-6)
- Average daily dose of oxymorphone ER(Entire study duration)
- Rescue medication.(Entire study duration)
- Total daily dose of oxymorphone ER and rescue medication(Entire study duration)
- Time to stabilization. Patient/investigator global assessments(Month 6)
- Treatment satisfaction(Month 6)
研究者
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