CTRI/2020/11/029447尚未招募4 期
Effectiveness and safety of Nefopam hydrochloride versus Tramadol in Patients with Acute/Acute-on- Chronic Pain: A Randomized, Parallel non-inferiority study.
Department of PharmacologyPGIMERChandigarh0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.Male and female patients above 18 years up to 60 years
- •2.Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigatorâ??s discretion throughout the study. Female of childbearing potential must have a negative pregnancy test and be non-lactating at baseline
- •3.The patient has read the ICF, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the ICF before the inclusion in the clinical study and the performance of any procedure
- •4.Moderate or severe pain (score of at least 50 mm on 100 mm VAS within 4 hours post-surgery or at the time of visit to the investigator) at baseline undergoing dental procedures requiring either of the two study medications or patients with back pain, neck pain or degenerative pain.
- •5.Patients with acute/acute-on-chronic pain, including post-operative, joint, or acute traumatic pain.
- •6.Patient is in good health, i.e., the medical record, vital signs, physical examination, and laboratory parameter assessments do not show any abnormal deviations impeding the participation in the clinical study at screening and baseline visit
- •7.Patient must be able to swallow the study drug
- •8.Patientwilling to fill patient diaries and comply with the study procedure and requirements. A patient/caregiver who is able to read, understand, and willing to sign and date written ICF
- •9.Patient who has shown suboptimal response to NSAIDs and other systemic therapies.
排除标准
- •Patient received any analgesic medication other than short-acting pre-operative or intra-operative anesthetic agents within 12 hours before taking the study drug
- •Received a long-acting NSAIDs within 3 days prior to dosing
- •History of any significant medical condition (e.g., significant psychiatric disorders [suicidal tendencies, emotional disturbance, depression etc] or neurological disorders[convulsive disorders, epilepsy, seizures],anaphylactoid reactions to codeine and other opioids, asthma, severe liver, hepatic, and renal dysfunction, peptic ulcer disease, acute abdominal conditions, ischemic heart disease, seizures, glaucoma, etc.), or any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the investigator felt would interfere with study evaluations and study participation
- •BMI >= 35 kg/m2
- •Participation in any other clinical study in past 30 days
- •Patientwho isonmonoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce the seizure threshold within 4 weeks of enrollment
- •Patient with central nervous system, respiratory depression, increased intracranial pressure or head injury and more in detailed protocol
研究者
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