EUCTR2005-005365-11-HU进行中（未招募）1 期
A randomised, 2-arm, parallel group study assessing safety and efficacy of titrated transdermal buprenorphine in patients with moderate to severe chronic non malignant pain - Titrated transdermal buprenorphine patch in moderate to severe chronic pain
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 246
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- At least 18 years of age at enrolment
- •- Subjects suffering from chronic non-malignant pain (of at least 3 months duration)
- •- Subjects with pain intensity of at least 5 on an 11-point NRS and requiring an equianalgesic dose range equivalent to 30 - 60 mg oral morphine per day
- •- Subjectsts taking = 325 mg acetylsalicylic acid (ASA) daily for cardiovascular prophylaxis who have been on a stable dose for = 30 days may be enrolled
- •- Males or non-pregnant, non-lactating, or postmenopausal females. Female patients of childbearing potential must use an acceptable method of contraception (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) during study period and have a negative urine pregnancy test (at screening).
- •- Expected course of the disease and the pain that will permit compliance with the study protocol over the entire study period
- •- The patient has been informed about the nature of the study, understood the information and given written informed consent before undergoing any study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Participation in another study parallel to or less than 30 days before study entry
- •- Alcohol and/or drug abuse in the investigator’s judgment, based on patient history and physical examination
- •- Positive urine test for drugs of abuse, other than prescription analgesic substances for a medical condition
- •- Subjects with respiratory depression in the absence of resuscitative equipment, and in patients with severely impaired respiratory centre/function, and in any patient who has or is suspected of having a paralytic ileus
- •- Subjects
- •who are opioid tolerant, or
- •have used opioids for any indication within 3 months of study start,
- •who have ever used opioids for longer than 6 months
- •- Previous and/or current unhealed extensive dermal damage in the area where the patch is to be applied (e.g., dermatitis, burns, scarring of the skin)
- •- Known hypersensitivity to any of the study medications, i.e., the active substance buprenorphine or to any of the excipients
- •- Any scheduled surgery and/or painful procedure during the course of the study
- •- History of seizure disorder, dementia and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin
- •- Intake of adjuvant analgesics (e.g. antidepressants, anticonvulsants, selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], muscle relaxants, bisphosphonates, corticosteroids, phytopharmaceutics), antiparkinsonian drugs, neuroleptics or laxatives if not on a stable dose within 30 days prior to the screening visit
- •- Concomitant intake and/or intake within 30 days prior to the screening visit of monoamine oxidase (MAO) inhibitors or anti-emetics
- •-TENS (transcutaneous electrical nerve stimulation), physiotherapy, acupuncture, and other adjunctive therapy if procedures are not stable, ie, performed at the same ferquency, within 30 days prior to the screening visit
- •- Patients suffering from myasthenia gravis
研究者
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