EUCTR2005-001656-21-FI进行中（未招募）不适用
A randomized, multi-center, double-blind, parallel-group, multiple-dose study assessing the analgesic efficacy and safety of 3 different doses of GRT0151Y compared to placebo and an active comparator in adults following tonsillectomy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
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. Male or female subjects aged 18 65 years inclusive at enrolment and study entry
- •2. ASA classification I-II
- •3. Planned bilateral tonsillectomy due to recurrent acute tonsillitis or chronic tonsillitis
- •4. Anesthesiological and surgical procedures performed according to the protocol
- •5. Moderate to severe postoperative pain at rest on 4 point VRS and a pain intensity at rest of minimum 4 on 11 point-NRS within 4 hours following the end of the anesthesia
- •6. Negative urine abuse test at the enrolment visit and pre operative examination. Subjects who declare that they are receiving benzodiazepines for medical purposes may participate even if they test positive.
- •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. Pregnancy or breastfeeding mother
- •2. Evidence or history of neurotic personality, psychiatric illness, epilepsy or suicide risk
- •3. Women of childbearing potential who does not use satisfactory contraception (i.e. double barrier, hormonal or IUD method) 28 days prior to enrolment visit, during the study and until 28 days after the follow-up visit.)
- •4. History of chronic hepatitis B or C, or HIV, or presence of active hepatitis B or C within the post 3 months. History of AIDS
- •5. Poor medical status (e.g. NYHA class = 3; child classification for hepatic impairment >A (Pugh et al., 1973); decompensated chronic obstructive pulmonary disease) or, at the discretion of the investigator, clinical signs that raise concerns about subject’s suitability for the study
- •6. Creatinine higher than 1.5X upper limit of normal range
- •7. ALT and/or AST higher than 3X upper limit of normal range
- •8. At enrolment ECG with findings which could impact operability or any planned study procedure: e.g. marked repolarization abnormality (e.g. suspicious or definite congenital long QT syndrome) and/or QT values of: QTCB females = 450 msec, QTCB males = 430 msec, uncorrected QT = 500 msec
- •pre-operative ECG with findings which could impact operability or any planned study procedure
- •9. Known contraindications/hypersensitivity to the comparator tramadol and rescue medication acetaminophen or diclofenac
- •10. Known contraindications/hypersensitivity to opioids or local anesthetics
- •11. Known coagulation disorder of any etiology
- •12. Use of anti-coagulants (heparin, warfarin or coumarin derivates) 4 weeks prior to surgery and during the whole treatment period
- •13. Chronic (=2 weeks) oral intake of corticosteroids less than 2 weeks prior to enrolment
- •14. Any chronic disease (e.g. hepatic, renal and/or gastrointestinal) that might affect drug absorption, metabolism or excretion
- •15. Use of analgesics, sedatives or narcotics 12 hours prior to surgery
研究者
相似试验
进行中（未招募）
1 期
A randomized, multi-center, double-blind, parallel-group, multiple-dose study assessing the analgesic efficacy and safety of 3 different doses of GRT0151Y compared to placebo and an active comparator in adults following tonsillectomyPostoperative pain following tonsillectomyMedDRA version: 8.0Level: LLTClassification code 10054711EUCTR2005-001656-21-GBGrünenthal GmbH
进行中（未招募）
1 期
A randomized, multi-center, double-blind, parallel-group, multiple-dose study assessing the analgesic efficacy and safety of 3 different doses of GRT0151Y compared to placebo and an active comparator in adults following tonsillectomyEUCTR2005-001656-21-CZGrünenthal GmbH450
进行中（未招募）
不适用
A randomized, multi-center, double-blind, parallel-group, multiple-dose study assessing the analgesic efficacy and safety of 3 different doses of GRT0151Y compared to placebo and an active comparator in adults following tonsillectomyEUCTR2005-001656-21-HUGrünenthal GmbH450
进行中（未招募）
1 期
Dose-ranging study of nemolizumab in atopic dermatitisAtopic dermatitisEUCTR2016-005025-37-PLGALDERMA R&D, SNC351
进行中（未招募）
1 期
Dose-ranging study of nemolizumab in atopic dermatitisAtopic dermatitisEUCTR2016-005025-37-FRGALDERMA R&D, SNC250