EUCTR2011-001903-10-ES进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, dose finding trial using sublingual alfentanil to alleviate pain associated with a prostate biopsy procedure
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Orexo AB
- 入组人数
- 200
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. Men 18 to 85 years of age at the time of eligibility at Visit 1.
- •2. Signed informed consent obtained.
- •3. Abnormal digital rectal examination and/or elevated total prostate-specific antigen (tPSA) value > 4.0 ng/mL or increased Prostate-Specific Antigen (PSA) velocity based on Investigator judgment for biopsy.
- •4. Body mass index (BMI) between 19.0 and 34.0 kg/m2 inclusive.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Previous prostate biopsy.
- •2. Prior radiation therapy to pelvis.
- •3. Anal fissure, anal stricture or any other anorectal pathology that may interfere with the prostate biopsy procedure, as judged by the Investigator.
- •4. Suspected urinary tract infection or recent (within 30 days) active urological infection (e.g., prostatitis).
- •5. Any known hypersensitivity or contraindication to alfentanil, other opioids or local anaesthetics.
- •6. A history or presence of drug or alcohol abuse.
- •7. Concomitant or prior use of opioids within 2 weeks prior to IMP administration.
- •8. Concomitant or prior use of any analgesic treatment for pain within 24 hours prior to IMP administration.
- •9. Concomitant or prior use of any sedating medications (e.g. barbiturates, benzodiazepines, neuroleptics, antihistamines) within 24 hours prior to IMP administration.
- •10. Concomitant use of monoamine oxidase inhibitors (e.g. Aurorix/moklobemid).
- •11. Concomitant or prior use of medium to strong cytochrome P450 (CYP) 3A4 enzyme inhibitors or 3A4 enzyme inducers within 14 days prior to IMP administration (pre-biopsy administration of antibiotics according to site standard practice is allowed, except for clarithromycin, erythromycin, telithromycin and rifampin/rifampicin. See Appendix 13.2 for prohibited medications).
- •12. Bleeding diathesis.
- •13. Anticoagulant treatment (aspirin up to max 160 mg/day is allowed).
- •14. Chronic pain and/or need of chronic pain treatment.
- •15. Current pain as measured by a score of > 3 on an 11-items Numerical Rating Scale (NRS).
- •16. Severe airway and lung disease such as symptomatic asthma, chronic bronchitis, emphysema or sleep apnea syndrome.
- •17. A history of any seizure disorder (other than febrile seizures).
- •18. A history of significant liver or renal disease.
- •19. A history of hypothyreosis.
- •20. Clinically significant cardiac disease or central nervous system disease.
- •21. Clinically significant abnormality detected in the patient?s physical examination, vital signs (including clinically significant abnormal orthostatic blood pressure) or 12-lead ECG as judged by the investigator.
- •22. History and/or presence of any somatic disease/condition that may interfere with the objectives of the trial as judged by the Investigator.
- •23. Participation in any other trial involving an IMP within 3 months before assessment of eligibility at Visit 1.
- •24. Otherwise not suitable to participate in the trial in the opinion of the Investigator.
研究者
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