Retrospective observational study to assess efficacy of Tapentadol nasal spray in moderate to severe back ache patients - NI

Dr Shobhan Mandal0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1 Patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute/ chronic low back pain that is felt down to the lower leg below the knee.
•2 Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance. Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening

•1 History of hypersensitivity to Tapentadol.
•2 Active or suspected gastrointestinal ulcers, bleeding, or motility disorders within the past 6 months prior to screening.
•3 Recent intranasal medication within the 72 hours preceding randomization.
•4 Analgesic administration post-operatively before enrolment.
•5 Concurrent use of tricyclic antidepressants, selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans, steroids, monoamine oxidase inhibitors, or drugs with potential to lower seizure threshold in the 4 weeks prior to enrolment.
•6 History of seizures.
•7 Mild to moderate traumatic brain injury, stroke, or brain neoplasm within the past year or severe traumatic brain injury within the last 15 days.
•8 Clinically significant ECG abnormalities or QTC greater than or equal to 450 msec for males and greater than or equal to 470 msec for females at screening.
•9 Pregnancy or lactation. Bronchial Asthma and COPD

发起方

Dr Shobhan Mandal