A Multicentric, Open-label, Single-arm, Non-comparative, Clinical Trial to EvaluateSafety and Efficacy of Tapentadol Nasal Spray in Patients with Moderate to Severe Pain
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
Tapentadol iscentrally acting analgesic with dual mechanisms of action: µ-opioid receptoragonism and norepinephrine reuptake inhibition. It is approved as immediaterelease tablet (50mg, 75 mg, 100mg) and extended release tablet (50mg, 100mg,150mg, 200mg, 250mg) in India for moderate to severe acute pain. Efficacyand safety of tapentadol nasal spray has been established in phase-III,multi-centric, randomized, open-label clinical trial. The tapentadol nasalspray is approved by the CDSCO for the treatment of moderate to severepost-operative pain. This phase 4 clinical trial is a Multicentric, Open-label,Single-arm, Non-comparative, Clinical Trial to Evaluate Safety and Efficacy ofTapentadol Nasal Spray in Patients with Moderate to Severe Pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects aged 18-65 years, both inclusive.
- •After weaning of anaesthesia post-surgery, patients having pain intensity score ≥ 4 on an 11-point (0 to 10) Numeric Pain Rating Scale (NPRS).
- •Patients having physical status of I-II according to American Society of Anaesthesiologists (ASA) classification.
- •Patient willing to give written informed consent to participate in the study.
排除标准
- •Patients with a history of hypersensitivity to tapentadol or any of the excipients.
- •Patients who have taken any medication by intranasal route within the 72 hours prior to enrolment.
- •Patients currently being treated with tricyclic antidepressants, selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants neuroleptics,triptans, monoamine oxidase inhibitors, steroids or other drugs that has potential to reduce the seizure threshold within the past 4 weeks prior to screening.
- •Patients with history of impaired pulmonary function (significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment), severe renal or hepatic impairment, suspected paralytic ileus or head injury.
- •Patient having history of clinically significant medical illness in past 3 months, which may compromise the patients’ safety or study outcome.
- •History of alcohol, other opioids, or illicit drug abuse within past 6 months and chronic use of any opioids for any disease in past 1 month.
- •Pregnant or lactating women.
- •In the opinion of the Investigator, patient is either unable to cooperate or unlikely to adhere with any study procedures.
- •Patients who have participated in any other investigational drug trial within the past four weeks prior to screening.
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: At the end of the study
次要结局
- Efficacy(1) Proportion of patients achieving 30% reduction in pain)