EUCTR2014-004718-27-PL进行中（未招募）1 期
A randomised, multicenter, single-blinded, parallel-group study to assess efficacy, safety and tolerability of the combination of Immediate Release (IR) tramadol with micronized magnesium lactate as functional excipient in management of chronic pain in subjects with osteoarthritis of the hip or/and knee.
Medical Unviersity of Warsaw0 个研究点目标入组 294 人开始时间: 2016年12月1日最近更新:
适应症
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
- 294
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
- •Only subjects to whom all of the following conditions apply will be included:
- •1. Males (not less than 35% of all subjects) and femalesaged 18-75 years.
- •2. For females, to have a negative pregnancy test at the Baseline (Visit 1) prior to administration of study medication.
- •3. Females ofnon-childbearing potential or if of childbearing potential, must use a medically acceptable form of contraception for the duration of the study.Females of non-childbearing potential are defined as those who are either surgically sterilised or at least one year post-menopausal.
- •4. Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate.
- •5. Adults with a clinical diagnosis of osteoarthritis of the hip and /or knee, based on American College of Rheumatology and radiographic criteria. The presence of typical knee or hip joint symptoms (pain, stiffness, disability) and signs (bony crepitus), and radiographic evidence of osteoarthritis (functional class I-III).
- •6. Subjects who have a baseline numeric rating scale pain intensity score (NRS-11) =4 (at Day 1) before randomisation to study treatments.
- •7. Subjects with hip or/and knee osteoarthritis who were judged by investigator as having suboptimal response to non-opioid treatment.
- •8. Willingness to withhold any medicines that may interfere with tramadol metabolism for 2 weeks prior to the start of the study and continue to withhold them during treatment periods.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 174
排除标准
- •Subjects to whom any of the following conditions apply must be excluded:
- •1. Inflammatory arthritis, gout, pseudogout, or Paget’s disease of bone that might interfere with the assessment of response.
- •2. Diagnosis of chronic pain syndrome (lasting longer than 3 months).
- •3. Clinical diagnosis of fibromyalgia or another major joint or connective tissue disease.
- •4. Inability to discontinue acetaminophen, COX-2 inhibitors, NSAIDs (other than aspirin <325 mg QD for cardiovascular prophylaxis), corticosteroids, or other analgesics for the duration of the clinical study.
- •5. Use of oral, intramuscular, intravenous, or soft tissue corticosteroids within 1 month prior to the study.
- •6. History of clinically significant intolerance to tramadol or a known hypersensitivity to opioid analgesics; and increased risk in terms of the precautions, warnings, and contraindications noted in the tramadol prescribing information.
- •7. History of clinically significant intolerance or a known hypersensitivity to non-steroid anti-inflammatory drugs; and increased risk in terms of the precautions, warnings, and contraindications noted in the diclofenac prescribing information. 8. Uncontrolled concomitant disease or chronic condition(s)need of medical treatment that might interfere with the assessment of pain and other symptoms of osteoarthritis including: Epilepsy in medical history; History of serious insufficiency of the kidney or liver; Parkinson disease; History of extrapyramidal symptoms; History of or current depressive disorders and antidepressive treatment being continued; History of unstable ischaemic disease, cardiac arrhythmia, unstable arterial hypertension.
- •9. History of, or reason to believe a participant has a history of narcotic or alcohol abuse as well as sedative drugs use including hypnotics, other analgesics like morphine or codeine and any other drugs that have a sedating potential.
- •10. HIV, Hepatitis B or C in subject history.
- •11. Treatment with MAO inhibitors within the period shorter than 30 days prior to study enrolment.
- •12. Antipsychotic or antidepressant or anticonvulsant used drugs or treatment during 2 weeks prior to study enrolment.
- •13. Miastenia gravis.
- •14. Tramadol or magnesium treatment being considered as contraindicated by investigator.
- •15. Use of any dietary supplements containing magnesium14 days prior to study enrolmentor during the study.
- •16. Ongoing treatment with calcium blockers, gabapentine, pregabaline and anticoagulant.
- •17. Body mass index (BMI) > 35.0 kg/m2.
- •18. Pregnancy and breast-feeding female.
- •19. Infirmity, disability or geographic location that would limit compliance for scheduled visits - subject at risk of non-compliance.
- •20. Any clinically significant abnormality or other serious or unstable medical or psychological condition identified in the subjects’ medical history, on physical examination or laboratory tests that, in the judgement of the investigator, would compromise the subjects’ safety or successful participation in this Study.
- •21. Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
研究者
相似试验
进行中（未招募）
不适用
A randomised, double-blinded, multicenter, parallel group study comparing a remifentanil-regimen with a fentanyl-regimen for analgesia in mechanically ventilated patientsmaschinell ventielierte Patienten auf der IntensivstationEUCTR2005-001907-21-DEKlinik für Anästhesiologie und operative Intensivmedizin, Charité – Universitätsmedizin Berlin160
已完成
不适用
A randomised, double-blinded, multicentre, parallel group study comparing a remifentanil-regimen with a fentanyl-regimen for analgesia in mechanically ventilated patientsAnalgesia in mechanical ventilationSigns and SymptomsAnalgesiaISRCTN45716767Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)160
招募中
1 期
A multicentre, randomized, single-blind, parallel-controlled study of acupoint catgut embedding for metabolic fatty liver diseaseITMCTR2100004943Shuguang Hospital affiliated to Shanghai Universtiy of Traditonal Chinese Medicine
已完成
不适用
A Multicenter, single-blind, randomized, parallel-group trial comparing Reinforced Reload with Tri-Staple with Tri-Staple during Distal PancreatectomyPatients who underwent distal pancreatectomyJPRN-UMIN000022341Hiroshima University Hospital120
招募中
2 期
A Multicenter, single-blind, randomized, parallel-group trial comparing stapler closure with Clip on Staple method with stapler closure alone during Distal PancreatectomyPatients who undergo distal pancreatectomyJPRN-UMIN000042217Kyushu Study group of Clinical Cancer (KSCC)188