EUCTR2006-001251-35-DK进行中（未招募）1 期
TO STUDY THE PERIPHERAL EFFECT OF BOTULINUM TOXIN-A (BOTOX-A) ON EXPERIMENTALLY INDUCED CUTANEOUS PAIN IN HEALTHY SUBJECTS
Aalborg University0 个研究点目标入组 30 人开始时间: 2006年6月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- Male
入选标准
- •1.Signed and dated Written Informed Consent
- •2.Male, 18 40 years of age
- •3.No concomitant medical diseases or clinically significant abnormal findings based on the medical history and baseline physical examination, that could affect the conduct of the study, analysis of the data, or the safety of a subject, as determined by the investigator.
- •4.In the opinion of the investigator, the subject clearly understands the intent of the study and is willing and able to comply with study instructions, is available for study visits and procedures and is anticipated to complete the entire study
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any medical condition that may put the subject at increased risk with exposure to Botox, such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function, including peripheral neuropathies.
- •2.Concurrent use or use within 30 days of screening of aminoglycoside antibiotics, curare like agents or other agents that might interfere with neuromuscular function
- •3.Known allergy or sensitivity to any of the ingredients in the study medication or any clinical supply materials.
- •4.Current or previous participation in another investigational drug or device study within 30 days prior to screening.
- •5.Current or previous use of any serotype of botulinum toxin, or anticipated need for treatment with or use of any serotype of botulinum toxin during the study (other than the study medication).
- •6.Recent history of drug or alcohol abuse.
- •7.Indications which in the investigator’s opinion, indicates inappropriate/illicit substance abuse, an underlying significant medical condition or which might interfere with the subject’s participation in the study.
- •8.Infection or dermatological condition at the sites of study medication injection or test site.
- •9.Family history of hereditary neuropathy.
- •10.Any disease associated with a peripheral neuropathy (diabetes, etc.)
- •11.Anticipated need for a medical procedure, surgery or overnight hospitalization during the study
- •12.Concurrent use of any drug
研究者
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