NCT02490436已完成2 期
A Randomized, Cross-over, Placebo-controlled, Double-blind, Single-center, Phase II Study of Cetuximab in Patients With Treatment-refractory, Non-malignant Severe Chronic Neuropathic Pain
Sorlandet Hospital HF1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in average neuropathic pain score using an 11-point numeric rating scale.
研究概览
简要总结
The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed informed consent and anticipated compliance.
- •Pain defined as "definite" neuropathic pain, according to the Special Interest Group on Neuropathic Pain guidelines or defined as "probable" NP, according to the guidelines, if the confirmatory test was a positive diagnostic test. Complex regional pain syndrome can be included despite lack of an offending lesion, as long as the "Budapest criteria" are fulfilled
- •Neuropathic Pain associated with compressive nerve states (including failed surgery) or CRPS (according to the "Budapest criteria")
- •PainDETECT score of at least 13 with average pain intensity of at least 6 /10 over the last four weeks. In addition, a painDETECT pattern indicating that the underlying neuropathic pain is constantly present.
- •Worst pain intensity higher than 6 for five of seven days during the screening phase, according to Brif Pain Inventory.
- •The patient should be able to distinguish between the neuropathic pain and other pain conditions, including elements of nociceptive pain caused by the same disease process.
- •Neuropathic pain duration of between six and thirty months, deemed chronic and likely to be irreversible by clinical history and findings.
- •No new or increased neuropathic pain treatment for the last four weeks.
- •Standard medical treatments for the patients' underlying condition or neuropathic pain must have been considered or tried and must, according to the opinion of the referring or a consulted pain specialist, be judged to be inappropriate or of insufficient potential efficacy.
- •Referring physician agreement to follow up the patient after study completion according to the best possible and available pain treatment and care.
- •Women of childbearing potential and men must use an acceptable method of contraception throughout the study, and for 30 days after the last study drug administration.
- •Negative pregnancy test within 7 days before each treatment period where appropriate.
- •White blood cell count ≥ 3 × 109 with neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin ≥ 6.21 mmol/L (10 g/dL). Total bilirubin ≤ 1.5 × upper limit of reference range and AST and ALT ≤ 2.5 × upper limit of reference range within the last 28 days before inclusion.
- •Aged 18 or above
排除标准
- •Neuropathic pain origin in the central nervous system.
- •Phantom limb pain or a significant component of nociceptive pain.
- •Ascending distal small fiber peripheral neuropathy.
- •Patients primarily experiencing pain 'attacks', i.e. pattern of neuropathic pain depicted in picture 3 of the painDETECT.
- •Other pain state that may interfere with evaluation of the studied neuropathic pain condition.
- •Any underlying medical or psychiatric condition, clinical disorder or laboratory finding, which in the opinion of the investigator may interfere with study objectives.
- •Uncontrolled or unstable diabetes.
- •Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias
- •Severe cerebrovascular disease during the six months prior to inclusion.
- •Active and ongoing eye and skin disorders or newly diagnosed gastric ulcer that may interfere with the study treatment.
- •History of allergic reaction to any of the study treatment components, red meat or tick bites.
- •Previous treatment with any EGFR-pathway inhibitor.
- •Women who are pregnant or breastfeeding.
- •Participation in another clinical trial within the past 90 days.
- •Use of any investigational agent within 90 days prior to day 1 of study drug.
- •Known drug abuse/alcohol abuse, legal incapacity or limited legal capacity or any other reason that, in the opinion of the investigator precludes the subject from participating.
研究组 & 干预措施
A: active drug first
Experimental
Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3.
干预措施: Cetuximab (Drug)
A: active drug first
Experimental
Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3.
干预措施: Placebo (Drug)
B: placebo first
Experimental
Placebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3.
干预措施: Cetuximab (Drug)
B: placebo first
Experimental
Placebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in average neuropathic pain score using an 11-point numeric rating scale.
时间窗: Days 4-8 after each infusion of cetuximab and placebo
次要结局
- Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average neuropathic pain score using an 11-point numeric rating scale.(Days 4-8 after each infusion of cetuximab and placebo)
- Comparison of frequency in all patients on active treatment of at least a 50% reduction of average neuropathic pain score using an 11-point numeric rating scale.(Days 4-8 after each infusion of cetuximab and placebo)
- Comparison of change in average worst neuropathic pain score using an 11-point numeric rating scale.(Days 4-8 after each infusion of cetuximab and placebo)
- Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.(Days 4-8 after each infusion of cetuximab and placebo)
- Comparison of frequency in all patients on active treatment of at least a 50% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.(Days 4-8 after each infusion of cetuximab and placebo)
- Patient Global Impression of Change.(7 days after each infusion.)
- Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo.(Days 4-8 after each infusion during treatment periods 1 and 2.)
- Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo.(Days 4-8 after each infusion during treatment periods 1 and 2.)
- 2-hourly waking time 11-point numeric rating scale (item #6 from the Brief Pain Inventory) in the first 24 hours and daily thereafter.(2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).)
- Number of AE and SAE recording(From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.)
研究者
研究点 (1)
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