EUCTR2012-003770-11-DK进行中（未招募）1 期
A multi-center, randomized parallel group pilot study to investigate the mechanism of action of tapentadol PR and oxycodone CR in subjects with osteoarthritis knee pain - GROSKNEEPA01
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- C4Pain ApS
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.Written informed consent (IRB/IEC specific) has been obtained prior to initiation of any protocol required procedures.
- •2.Male or female between 40 and 80 years of age. Females of childbearing potential must have a negative urine pregnancy test at screening.
- •3.Body weight >40 kg and <150 kg with a body mass index (BMI) between 19-40 kg/m2 inclusive.
- •4.Idiopathic osteoarthritic knee pain (index knee) diagnosed in accordance with the American College of Rheumatology (ACR) modified clinical classification criteria (Altman et al, 1986) and verified radiologically as Kellgren-Lawrence grade I, II or III (Kellgren and Lawrence, 1957) at the index knee. The clinical diagnosis of OA will be confirmed by the ACR clinical and radiographic criteria for classification of idiopathic OA based upon the following criteria (index knee):
- •a.Knee pain for at least 14 days per month for the 3 months before study entry.
- •b.Osteophytes (with radiographic evidence).
- •c.And at least 1 of the following 3 conditions: Age >50, or morning stiffness <30 minutes, or crepitus.
- •d.X-ray images of the knee joints are available confirming OA. X-ray images older than12 months cannot be used. New photos are needed to confirm the diagnostic criteria for OA.
- •5.For the index knee, the average of the worst daily pain score over the last 14 days prior to day 0 (i.e. days -14 to day -1) must be 5.0 to 9.0. The 14-day average score will be derived from worst daily pain scores recorded in a diary for the index knee.
- •6.Discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics/ Non-Steroidal Anti-Inflammatory Drug (NSAID) at least 3 days prior to visit 2 (subjects are allowed limited use of analgesic medications, refer to section on Permissible Medications/Treatments).
- •7.Have agreed to maintain the same activity level throughout the course of the 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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. A history of recurrent seizures other than febrile seizures.
- •2. A history of frequent and/or severe allergic reaction with multiple medication.
- •3. A current or recent history, as determined by the investigator or his delegates, of severe, progressive, and/or uncontrolled renal, including severe renal impairment, hepatic, including severe impaired liver function, hematological, gastrointestinal, endocrine, pulmonary, including respiratory depression, COPD or acute severe asthma, cardiac, including cor pulmonale, neurological, psychiatric or cerebral disease which could interfere with the subject's participation in the study.
- •4. At screening, have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study. In addition, subjects with following findings will be excluded:
- •a. Confirmed Bazett’s corrected QT (QTcB) interval > 450 msec for men and > 470 msec for women at screening.
- •b. Bundle branch blocks and other conduction abnormalities other than: i) mild first degree atrio-ventricular block, ii) left anterior hemi block due to left axis deviation, iii) right bundle branch block of benign origin i.e. not caused by other cardiac disease.
- •c. Irregular rhythms other than sinus arrhythmia or occasional supraventricular or ventricular ectopic beats,
- •d. History of unexplained syncope,
- •e. Family history of unexplained sudden death or sudden death due to long QT syndrome,
- •f. T-wave configurations are not of sufficient quality for assessing QT interval determination, as assessed by the investigator.
- •5. An alanine aminotransaminase. Moderate or greater hepatic impairment.
- •6. Prior renal transplant, current renal dialysis or severe renal insufficiency or serum creatinine.
- •7. Pregnant female, breast feeding or planning a pregnancy during the study period. Females of child-bearing potential, not using a reliable means of contraception (refer to section 8.5.3 – reliable contraception).
- •8. Active malignancy of any type or a history of malignancy within the last 5 years (except basal cell carcinoma of the skin that has been excised prior to study start).
- •9. Any excluded medications (analgesic medications) that cannot be discontinued during the screening period (3 days prior to visit 2).
- •10. Treatment within the last 30 days with a drug that has not received regulatory approval.
- •11. Substance abuse or dependence, not nicotine/caffeine.
- •12. A high risk of infection.
- •13. A history of, or suspected, demyelinating disease of the central nervous system.
- •14. An autoimmune disorder.
- •15. Not fully understand the EPM procedures.
- •16. Investigator site personnel directly affiliated with this study and/or their immediate family.
- •17. Diagnosed with any condition suggestive of a secondary cause of knee OA.
- •18. History of surgery in the index knee within 3 months or planned surgery.
- •19. Complicated prior injury to the index knee within 12 months.
- •20. Diagnosed with Kellgren and Lawrence grade 0 or IV.
- •21. Use of lower extremity assistive devices.
- •22. Prior synovial fluid analysis showing a WBC=2000mm.
- •23. A confounding painful condition that may interfere with assessment.
- •24. Any other musculoskeletal or arthritic condition that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study.
- •25. Have used corticosteroids prior to baseline: a. Intra-articular injection of steroids into the index knee or in
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