Efficacy and Safety of Prolonged Release (SR) Tramadol Hydrochloride (HCl)/Paracetamol fixed combination and Immediate Release (IR) Tramadol HCl/Paracetamol fixed combination in Patients with Moderate to Severe Acute Low-Back Pain - TreaSuRe

Krka, d.d., Novo mesto0 个研究点目标入组 313 人开始时间: 2016年1月7日最近更新: 2024年9月9日

研究概览

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•Patients diagnosed with acute low back pain (12 weeks or less of symptoms).
•Patients whose average pain intensity is more than or equal to 40 millimeters on horizontal Visual Analog Scale (VAS) over the last 48 hours after the completion of screening.
•Female and male patients aged 18-75 years.
•Written informed consent.
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Hypersensitivity to the active substances or to any of the excipients.
•Patients taking Monoamine oxidase (MAO) inhibitors or are within two weeks of their withdrawal.
•Patients taking neuroleptics or drugs for seizures.
•Severe hepatic impairment.
•Patients on maintenance tramadol and/or paracetamol therapy.
•Patients taking sedative hypnotics, short-acting analgesics, topical medications and anesthetics, and/or muscle relaxants.
•Pregnant, lactating or breastfeeding participants.
•Known or suspected alcohol or drug abuse or addiction within three years preceding screening.
•Patients with unstable angina pectoris or after acute myocardial infarction (4 weeks after acute myocardial infarction).
•Other mental disorders (possible interactions with mental disorder medicines).
•Surgical procedures planned to occur during trial (patients may be rescreened following completion of and recovery from the surgical procedure).
•Concomitant treatment that might influence the final therapeutic effect of the tested active substances.
•Concomitant therapy with either selective serotonin reuptake inhibitors (SSRI) or serotonin–norepinephrine reuptake inhibitors (SNRI).
•Patients who under the opinion of the investigator will not be compliant to the treatment.

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