Health Condition 1: S399- Unspecified injury of abdomen, lower back, pelvis and external genitals
Conditions
Interventions
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects aged 18-65 years, both inclusive. Patients undergoing Day Care Surgeries including Anal fissures, Anal fistula, Hemorrhoids, Hernia After weaning of anaesthesia post surgery patients having pain intensity score less than 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: Numeric Pain Rating Score change at day 5 Responder rate greater than or equal to 50 percent drop in NRS 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 & at the end of study at day 5Timepoint: 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 & at the end of study at day 5 | — |
Countries
India
Contacts
Public ContactDr Krishna Prasad K
Abhishek Day Care Health
Outcome results
None listed