EUCTR2006-004075-36-HU进行中（未招募）不适用
A randomized, double blind, placebo-controlled, single-dose, parallel-group comparison of the analgesic efficacy, safety and local tolerability of intravenous Paracetamol 1% solution Bioren (test), Perfalgan® 1% (reference), and placebo in a post-surgical total hip replacement model - Paracetamol in Orthopaedic pain
Baxter R&D Europe S.C.R.L.0 个研究点开始时间: 2007年2月13日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Subject has provided written informed consent prior to performing any study related procedures.
- •2. Male / female subjects, 18-75 years of age inclusive.
- •3. Body mass index (BMI) 18-40 inclusive.
- •4. Subject is in good health as determined by the Principal Investigator on the basis of medical history and physical examination.
- •5. American Society of Anesthesiologists (ASA) Grade I, Grade II or Grade III, scheduled for elective total hip replacement, using a standard approach and a cemented implant.
- •6. A negative urine pregnancy test for all female subjects of childbearing potential (a female is considered to be of childbearing potential if they have not been postmenopausal for at least 24 consecutive months or if they have a uterus and at least one ovary) immediately before surgery (performed on the ward in the morning of the procedure).
- •7. Subjects will be randomized and assigned medication if they rate their pain as moderate or severe assessed on a four-point verbal rating scale (VRS) within 4 hours of stopping the PCA in the morning of the first post-operative day.
- •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
- •1. Another acute or chronic painful physical condition (e.g.: concomitant malignant disease).
- •2. The subject requires a total hip replacement due to a fracture of the hip.
- •3. The use of non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, within the 12 hours preceding administration of study medication.
- •4. The use of any other analgesic drugs (except morphine administration by PCA) within the 12 hours preceding administration of study medication.
- •5. Specifically excluded are tricyclic antidepressants (TCAs), antihistamines, tranquilizers, hypnotics, sedatives and Cyclooxygenase-2 (COX-2) specific inhibitors.
- •6. The use of any corticosteroid drugs within the 7 days preceding administration of study medication.
- •7. The subject has a history of uncontrolled chronic disease, which in the opinion of the Principal Investigator would contraindicate study participation.
- •8. The subject has a disease/condition that is known to be a contraindication for treatment with morphine.
- •9. Inability to use or understand the visual analog scale (VAS) pain score
- •and/or the Verbal Rating Score (VRS).
- •10. Known hepatic disorders: Liver dysfunction defined as an elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma glutamyl transpeptidase (GGT) 2 times above the upper limit of normal (ULN).
- •11. Known renal disorders: Advanced renal dysfunction defined as an elevation of serum creatinine 2 times the ULN.
- •12. Known genetic defect of glucose-6-phosphate-dehydrogenase.
- •13. Psychiatric or medical conditions which would preclude safe surgery.
- •14. Concomitant use of microsomial enzyme inducers (see Appendix B).
- •15. Pregnant or breast feeding women.
- •16. Women of childbearing potential not using adequate contraception (one method of contraception is considered to be adequate).
- •17. Known sensitivity to the NSAID class of drugs, paracetamol or other analgesics.
- •18. A contraindication to paracetamol.
- •19. History of non-response to paracetamol.
- •20. A bleeding disorder.
- •21. Any history of gastrointestinal bleeding.
- •22. Any laboratory abnormality, which in the opinion of the Principal Investigator would preclude study participation.
- •23. History of analgesic, narcotic or alcohol dependence (substance abuse).
- •24. History of participating in another clinical investigation, or taking another investigational drug within 1 month prior to surgery.
- •25. Dehydration or chronic malnutrition.
- •26. Confined persons and prisoners.
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