Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain: An Open Label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale
研究概览
简要总结
The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.
详细描述
Neuropathic pain state is usually refractory to most analgesic regimens and requires polypharmacy for symptomatic relief. Current treatment options for neuropathic pain include both oral and topical medications. Most commonly prescribed oral treatments include antidepressants (eg, amitriptyline, desipramine, and duloxetine), antiepileptics (eg, gabapentin, pregabalin), and opiates such as tramadol and morphine. Current topical treatments include the lidocaine patch and the capsaicin patch. Many patients have inadequate pain relief in spite of these treatment options.
Currently, there are no treatments available for treatment of neuropathy itself other than treating the underlying cause and addressing the symptomatic relief for pain. Current drug therapies for neuropathic pain provide inadequate pain relief and undesirable side effects including sedation and cognitive dysfunction. It is not uncommon to use a combination of agents for the treatment of neuropathic pain to minimize the side effects. Although treating the mild to moderate pain may be relatively easy, it is very challenging for severe neuropathic pain. Although the use of opiates for neuropathic pain is well accepted, it remains controversial because of the potential for abuse and diversion.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals with chronic pain of more than 6 months duration
- •pain is determined to be secondary to a documented neuropathy
- •patients who are tolerant of opiates (60 mg of morphine or equivalent for at least one week)
- •male or female patients aged 18-75 yrs and have signed a written informed consent form and privacy statement
- •female patients of child-bearing potential must be using an acceptable form of birth control
排除标准
- •pregnant or lactating women
- •allergy to morphine or its derivatives
- •history of alcohol or substance abuse in the last 3 yrs
- •participation in any other clinical trial in the last 30 days
- •uncontrolled pain
- •patient who is deemed to be medically unstable by principal investigator
- •history of severe lung disease or asthma that is deemed medically significant by principal investigator
研究组 & 干预措施
Hydromorphone
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale
时间窗: Baseline visit to Week 12 or last visit
The primary efficacy measure was the change from baseline to end of study on question #5 ("average pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain on the average," where 0 = no pain and 10 = pain as bad as you can imagine.
次要结局
- Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours(Baseline visit to Week 12 or last visit)
- Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours(Baseline visit to Week 12 or last visit)
- Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now(Baseline visit to Week 12 or last visit)
- Sleep Quality Assessment (SQA)(Baseline visit to Week 12 or last visit)
- Pain Quality Assessment Scale (PQAS)(Baseline visit to 12 weeks visit)
- Global Assessment of Treatment Satisfaction(Baseline visit to Week 12 or last visit)
研究者
Srinivas Nalamachu
MD
International Clinical Research Institute
