Health Condition 1: R52- Pain, unspecified
Conditions
Interventions
Intervention1: Tapentadol HCl nasal spray
: dose-45
mg (one spray in each nostril) / 22.5 mg (one spray in single nostril)
Frequency:Eligible patients will be administered tapentadol nasal spray
45mg
Sponsors
TORRENT PHARMACEUTICALS LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 enrolment. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse eventsTimepoint: At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1) Proportion of patients achieving 30% reduction in pain 2) Proportion of patients achieving 50% reduction in painTimepoint: at the end of study | — |
Countries
India
Contacts
Public ContactDr Ram Gupta
TorrentPharmaceuticals Limited
Outcome results
None listed