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

TORRENT PHARMACEUTICALS LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

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•1.Male or female subjects aged 18-65 years, both inclusive.
•2. After weaning of anaesthesia post-surgery, patients having pain intensity score >= 4 on an
•11-point (0 to 10) Numeric Pain Rating Scale (NPRS).
•3. Patients having physical status of I-II according to American Society of
•Anaesthesiologists (ASA) classification.
•4. Patient willing to give written informed consent to participate in the study.

•Patients with a history of hypersensitivity to tapentadol or any of the excipients.
•2. Patients who have taken any medication by intranasal route within the 72 hours prior to
•3. 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.
•4. 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.
•5. Patient having history of clinically significant medical illness in past 3 months, which may compromise the patientsâ?? safety or study outcome.
•6. 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.
•7. Pregnant or lactating women.
•8. In the opinion of the Investigator, patient is either unable to cooperate or unlikely to
•adhere with any study procedures.
•9. Patients who have participated in any other investigational drug trial within the past four
•weeks prior to screening.

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