NCT02028923终止3 期
Phase III Study Evaluating the Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 5
- 主要终点
- Proportion of patients whose maximum daily consumption in immediate-release oral morphine is less than or equal to 30 mg for the last 72 hours of the study
研究概览
简要总结
This phase III study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female, aged over 18 years
- •Painful chronic wounds (bedsores, wound tumor, arterial ulcers, venous or mixed diabetic ulcer if systolic pressure index >0.8, necrotic angiodermatitis not graftable), a bottom surface 300 cm² and does not require more than 15 ml of gel by application. When patient has multiple painful chronic wounds, the wound having only the highest pain intensity is considered for evaluation.
- •Ineffective systemic analgesic with or without opioid analgesic established and maintained at the same dose for 3 days before inclusion. If treatment includes morphine, the daily dose should not exceed 60 mg of morphine equivalent and this treatment must be a treatment exclusive background.
- •Patient requiring an analgesic equilibration for intense and rebellious local pain, with a daily average score greater than or equal to 5, on a graduated numerical scale of 0 to
- •The score is defined at the inclusion and corresponds to the pain intensity felt locally by the patient under treatment systemic analgesic with or without co-analgesics.
- •If analgesics to treat systemic pain is ongoing, it must have been introduced for more than 3 days (according to criteria 3)
- •If antidepressant treatment is in progress, it must have been established for over a month for a tricyclic and for more than 15 days for other classes of antidepressants.
- •If an anti-epileptic treatment analgesic is in progress, it must have been established for over 15 days.
- •Signing of the informed consent form.
- •Patient able to respond the self-assessment questionnaires (sufficient understanding assessments, proficiency in French).
- •Patient affiliated to an health insurance plan
排除标准
- •Allergy to morphine or carboxymethylcellulose or history of intolerance to morphine
- •Analgesic at baseline including systemic morphine to greater than 60 mg equivalent dose of morphine treatment
- •Fistulated wound
- •Heavily exuding wound
- •Wound bleeding (spontaneous bleeding)
- •Ongoing radiotherapy on chronic wound
- •Creatinine > 110 µmol/L, Total bilirubin > 20 µmol/L
- •Not communicating patient
- •Unable to comply with requirement of the protocol (11 days)
- •Patient pregnant or of childbearing age without contraceptive therapy or lactating
- •Person deprived of liberty or under guardianship
- •Only for pharmacokinetic analysis: analgesics at baseline including morphine or hydromorphone or oxycodone or codeine. Fentanyl is allowed
研究组 & 干预措施
Morphine gel
Experimental
morphine 30 mg, quantity of gel per application: 15mg (15ml)
干预措施: Morphine gel (Drug)
Neutral gel
Placebo Comparator
water for injection, quantity of gel per application: 15mg (15ml)
干预措施: Neutral gel (Other)
结局指标
主要结局
Proportion of patients whose maximum daily consumption in immediate-release oral morphine is less than or equal to 30 mg for the last 72 hours of the study
时间窗: 11 days
Proportion of patients whose maximum daily consumption in immediate-release oral morphine is less than or equal to 30 mg (either up to 3 tablets 10 mg per day) for the last 72 hours of the study (day 8 to day 11) and for which the basic treatment is unchanged throughout the duration of the study
次要结局
- Evaluate the impact score of local pain on sleep (self-report scale of 0 to 100%)(11 days)
- Reduction in average daily pain intensity score on a numerical rating scale self assessment, measured on an 11-point between day 1 and day 11(11 days)
- Evaluate the percentage of local pain relief for 24 hours on a rating scale from 0 to 100%(11 days)
- Assess and characterize the evolution of local pain on a global impression scale change : Pain related Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC)(11 days)
- Determine the time (in hours) before using oral immediate-release morphine after application of local treatment(11 days)
- Evaluate the systemic absorption of topical morphine blood test after the first application(11 days)
- Assess patient satisfaction with treatment of local pain (score 0-4)(11 days)
- Determination of cumulative dose of oral immediate-release morphine (in milligrams) of the 11 days of treatment for relieving painful access of local origin(11 days)
- Evaluate systemic and local side effects of analgesic treatment (incidence, severity and location)(11 days)
研究者
研究点 (5)
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