CTRI/2019/03/018143已完成3 期
A Multicentric, Randomized, Open Label Clinical Trial to Evaluate Efficacy and Safety of Tapentadol Nasal Spray in Comparison to Tramadol Immediate Release Capsule and Intravenous Injection in Patients with Post-Operative Moderate to Severe Pain
Torrent Pharmaceutical Ltd23 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2019年1月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 23
- 主要终点
- 1. Pain intensity difference
研究概览
简要总结
Tapentadol is centrally acting analgesicwith dual mechanisms of action: µ-opioid receptor agonism and norepinephrinereuptake inhibition. It is approved as immediate release tablet (50mg, 75 mg,100mg) and extended release tablet (50mg, 100mg, 150mg, 200mg, 250mg) in Indiafor moderate to severe acute pain. In phase I studies conducted inhealthy volunteers, Tapentadol nasal spray has been found safe andwell-tolerated without any serious adverse events. The objectives of this Phase III study are to evaluate the efficacy and safety of Tapentadol nasal spray in comparisonto Tramadol immediate release tablet and intravenous injection in patients withpost-operative moderate to severe pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Male or female subjects of 18-65 years of age, both inclusive.
- •Patient is fit for surgery under general anaesthesia or regional anaesthesia
- •Patients having physical status of I-II according to American Society of Anaesthesiologists (ASA) classification.
- •After weaning of anaesthesia post-surgery, patients having pain intensity score ≥ 4 on an 11-point (0 to 10) Numeric Pain Rating Scale (NPRS).
- •Patient willing to remain hospitalized for a minimum of 5 days post-surgery.
- •Patient willing to give written informed consent to participate in the study before undergoing surgical intervention.
排除标准
- •Patients with a history of hypersensitivity to Tapentadol or Tramadol.
- •History of active or suspected gastrointestinal ulcers or bleeding or motility disorder within the past 6 months prior to screening.
- •Patient who will undergo either laparoscopic surgeries (eg.
- •laparoscopic cholecystectomy, laparoscopic appendectomy) or cardiothoracic surgeries (eg.
- •heart bypass surgery, open esophagectomy) or cancer surgeries (eg.
- •mastectomy).
- •Patients who have taken any medication by intranasal route within the past 72 hours prior to randomization.
- •Patients who have received analgesic postoperatively prior to randomization.
- •Patients with chronic use of any opioids for any disease within the last 28 days prior to screening.
- •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 having clinically significant postoperative complications before randomization which may compromise safety of the patient or study outcome as per investigator opinion.
- •History of any seizure disorder or epilepsy.
- •Patients with history of mild to moderate traumatic brain injury (loss of consciousness ≥ 30 minutes to 6 hours), stroke or brain neoplasm within past 1-year or severe traumatic brain injury (loss of consciousness ≥ 6 hours) within past 15 years prior to screening.
- •Patients with clinically significant ECG abnormalities or QTc ≥ 450 msec for male or QT ≥ 470 msec for female at screening.
- •Any clinically significant abnormal nasal or respiratory tract conditions i.e., atrophic rhinitis, nasal polyp, upper respiratory tract infection etc.
- •which can interfere with the absorption of the drug.
- •History of drug abuse or known active alcohol abuse within past 6 months.
- •Patients with liver enzymes (Alanine transaminase, Aspartate transaminase, Alkaline phosphatase) > 2.5X the upper limit of normal value (ULN) or total bilirubin >1.5X of ULN or serum creatinine >1.5X of ULN at screening.
- •Patients having respiratory rate less than 12 breaths per minute or greater than 20 breaths per minute at randomization.
- •History of active Hepatitis B or Hepatitis C or HIV infection.
- •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
1. Pain intensity difference
时间窗: 1. Pain intensity difference at 60 minutes | 2. Patient Global Assessment at 24 hours | 3. Sum of Pain Intensity Difference at 60 minutes
2. Patient Global Assessment
时间窗: 1. Pain intensity difference at 60 minutes | 2. Patient Global Assessment at 24 hours | 3. Sum of Pain Intensity Difference at 60 minutes
3. Sum of Pain Intensity Difference
时间窗: 1. Pain intensity difference at 60 minutes | 2. Patient Global Assessment at 24 hours | 3. Sum of Pain Intensity Difference at 60 minutes
次要结局
- 1. Sum of Pain Intensity Difference(2. Meaningful pain relief)
研究者
研究点 (23)
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