A Phase 3 Double Blind, Randomized, Placebo Controlled, Cross-Over Trial to Asses the Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Does nightly use of CALPXT96 improve sleep in patients with CNCP?
研究概览
简要总结
California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild sedative and/or sleep aid. However there are no human clinical trial data to support its use. Sleep disturbances are a well-recognized component of chronic pain, and lead to additional social withdrawal, greater pain and worsening depression. Most hypnotics available either place the patient at further risk (e.g. benzodiazepines combined with opioids increase the risk of central or obstructive sleep apnea), increase adverse events (dry mouth, daytime somnolence, etc.) or induce sleep but do not improve the quality of sleep (no increase in Rapid Eye Movement or curative sleep). This study intends to use California Poppy to avoid adverse effects while improving sleep. An open-label clinical trial was performed to obtain preliminary safety and efficacy information of California poppy. This trial was approved by a central ethics review board. The study results showed that California poppy, can be used as a co-analgesic to provide additional analgesia and/or sleep improvement to the patient. Patients who are referred to the clinic will be asked to complete a few short questionnaires at every visit and on monthly basis respectively. This data, in addition to the usual follow-up questionnaires used by the clinics' physicians (McGill Pain Intensity, Pain Disability Index, Short-form Health Survey-12v2) and general demographic and medical information will be used to assess California Poppy's effectiveness on patients
详细描述
Study Design:
This will be an 'n of 1' model, with the patient acting as their own control. To identify any possible negative 'wash out' effect after cessation of the active medication (that could negatively impact the 'no drug' arm) we have to do the following. After baseline documentation with standardized scales, randomize to one of 2 arms:
- Arm A
- 1st treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)
- 2 week wash out period
- 2nd treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)
- Arm B
- 1st treatment period: 4 weeks placebo (two capsules of CALPXT96 hs)
- 2 week ash out period
- -2nd treatment period: 4 weeks active drug (two capsules of CALPXT96 hs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age > 17 and < 75
- •Chronic non-cancer pain (CNCP) associated with a complaint of poor sleep. Validated tool the Pittsburgh Sleep Quality Index (PSQI) for sleep dysfunction and using a suitable cut points (PSQI >/=5) to ensure greater homogeneity of the sample and the recruitment of only those with significant pain related sleep disturbance.
- •Stable pain management therapy for 1 month prior to entry into the study
- •Having a confirmed diagnosis of CNCP for greater than 1 year
- •Written informed consent obtained.
- •Subject agreed to follow the protocol.
排除标准
- •Taking a hypnotic medication at time of enrollment. Patients may be enrolled if they are willing to cease any current hypnotic for at least 2 weeks prior to commencing the study
- •Current alcohol abuse or other addiction
- •Sleep apnea disorder
- •Inability to understand and comply with the instructions of the study
- •Previous enrollment in the study
- •Renal and/or liver insufficiency
- •Patients less than age 18
- •Pregnancy or lactation
- •Current (</=one year) DSM-IV Axis I diagnosis of major depressive disorder, dysthymia, generalized anxiety disorder and DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by patient history
研究组 & 干预措施
CALPXT96
- 1st treatment period: 4 weeks CALPXT96 (two capsules hs at bedtime)
- 2 week wash out period
- 2nd treatment period: 4 weeks placebo (two capsules hs at bedtime)
干预措施: CALPXT96 (Drug)
Placebo
- 1st treatment period: 4 weeks placebo (two capsules hs at bedtime)
- 2 week wash 'out' period
- 2nd treatment period: 4 weeks CALPXT96 (two capsules hs at bedtime)
干预措施: CALPXT96 (Drug)
结局指标
主要结局
Does nightly use of CALPXT96 improve sleep in patients with CNCP?
时间窗: Change from Baseline in PSQ-3 at Days 15, 30, 44, 59 and 74.
Changes in quality of sleep as measured by the Pain and Sleep Questionnaire (PSQ-3).
次要结局
- Does CALPXT96 improve functionality as defined by the PDI (or SF12)?(Change from Baseline in PDI (or SF12) at Days 15, 30, 44, 59 and 74.)
- Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)?(Change from Baseline in BPI at Days 15, 30, 44, 59 and 74.)
- Does CALPXT96 allow for a decrease in other medications prescribed for pain?(Change from Baseline at Days 15, 30, 44, 59 and 74.)