Efficacy, Safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain - GRT6005 in subjects with chronic low back pain

Grunenthal0 个研究点目标入组 70 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 70

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Informed consent signed.
•2. Male or female subject 18 years to 80 years of age at Visit 1.
•3. Women of childbearing potential must have a negative urine * human chorionic gonadotropin
•(*-hCG) pregnancy test at Visit 1 and at Visit 3.
•4. Subjects must be using medically acceptable and highly effective methods of birth control as defined in protocol page 35 and 36. Women of non-childbearing potential may be included if surgically sterile (i.e., after hysterectomy) or post-menopausal for at least 2 years.
•5. Subjects must be able to communicate meaningfully and able to differentiate with regard to location and intensity of the pain, and to complete the questionnaires used in this trial.
•6. Documented clinical diagnosis of chronic LBP of non-malignant origin and pain present for at least 3 months.
•7. Average 24-hour pain *5 on an 11-point NRS during the 3 days prior to Visit 3 without the use of rescue medication. Subjects must have 3 out of three 24-hour pain assessments during this 3-day period.
•8. Subjects must be on stable analgesic medications (non-opioid and/or opioid medications) for their chronic LBP with regular intake (i.e., at least 4 days per week) for at least 3 months prior to Visit 1 according to their medical history and dissatisfied with current analgesic treatment.
•9. Subjects requiring opioid treatment must be taking daily doses of opioid-based analgesic equivalent to*160 mg of oral morphine.

排除标准

•1. Concurrent participation in another trial, or within 30 days before Visit 1 of this trial.
•2. Previous participation in this or other trials with GRT6005 (unless enrollment failure due to technical reason). Exception: subjects who failed enrollment in this trial only because of the exclusion criteria that were changed in amendment 01 and 02, but for no other reason, and who may now be eligible may be re-enrolled.
•3. Previous or current alcohol or drug abuse or opioid dependency according to the investigator*s judgment,based on subject*s history, physical examination, or the result of the drug test at Visit 1 or at Visit 3.
•4. Female subjects who are pregnant or are breastfeeding
•5. Known or suspected of not being able to comply with the protocol and with the use of the IMPs or rescue medication.
•6. Any clinically significant disease or laboratory findings that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subject*s safety during trial participation, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological, or psychiatric disorders.
•7. Employees of the investigator, trial site, or sponsor, with direct involvement in the proposed trial or other trials under the direction of that investigator, trial site, or sponsor, as well as family members of employees or the investigator.
•8. Subjects with moderate to severe functional hepatic impairment corresponding to Child-Pugh classification B and C. Subjects with impaired hepatic cellular integrity shown by ALT or ASAT values higher than 3 times ULN
•9.History of acute hepatitis within 3 months of Visit 1or chronic hepatitis or a positive result on antihepatitis A IgM antibody within 6 months of visit 1, hepatitis B surface antigen, or anti*hepatitis C antibody. History of human immunodeficiency virus (HIV) infection.
•10.Subjects with impaired renal function. Creatinine clearance less than 45 mL/min at Visit 1 (calculated from the Cockcroft Gault formula).
•11. History of any major gastrointestinal prior procedures (e.g., gastric byepass) or gastrointestinal conditions (e.g., acute diarrhea, blind loop syndrome, gastric dumping syndrome, Whipple`s disease) that might affect the absorption or metabolism of GRT6005.
•12.Presence of risk factors for Torsade de Pointes (e.g.,heart failure, hypokalemia, bradycardia, long QT syndrome)
•13.Presence of QTcF >450 ms at Visit 1.
•14. History of seizure disorder and/or epilepsy or any condition associated with a significant risk for seizure disorder or epilepsy at Visit 1 at the discretion of the investigator.
•15.History or presence of malignancy, with the exception of curative treated subjects or subjects
•being in remission of cancer for at least 2 years and not requiring treatment.
•16. Subjects with chronic LBP potentially associated with a specific spinal cause (e.g., known high-grade spondylolisthesis [Grade 3 or 4], tumor, infection, vertebral compression fracture [history *1year], Paget*s disease, absolute spinal stenosis).
•17. Subjects with >1 previous low back surgeries or recent low-back surgery (within the last 12 months) or scheduled low back surgery during the trial or any other scheduled surgery or painful procedure during the course of the trial that, in the opinion of the investigator, may affect efficacy or safety assessments.
•18. Any invasive procedures aimed to reduce

研究者

发起方

Grunenthal

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