Health Condition 1: S381- Crushing injury of abdomen, lowerback, and pelvis
Conditions
Interventions
Intervention1: Tapentadol HCl: 45 mg : one spray (22.5 mg/100µL) in each nostril
22.5 mg : one spray (22.5 mg/100µL) in a single nostril
Formulation: Nasal spray
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects aged 18-65 years both inclusive Clinical cases of Hip surgeries Knee surgeries, and major surgeries After weaning of anesthesia post-surgery, patients having pain intensity score greater than or equal to 4 on an 11-point (0 to 10) Numeric Pain Rating Scale (NPRS)
Exclusion criteria
Exclusion criteria: Patients with a history of hypersensitivity to tapentadol or any of the excipients 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric Pain Rating Score change at Day 5 Responder rate (greater than or equal to 50 percent drop in NRS) at Day 5 Timepoint: at day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient global assessment at 24 hours after treatment initiation & at the end of study Clinical Global Impression Efficacy Index after 24 hours after treatment initiation and at the end of study day 5Timepoint: at day 5 | — |
Countries
India
Contacts
Public ContactDr Krishnaprasad K
DY Patil
Outcome results
None listed