Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Dr Shobhan Mandal
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute/ chronic low back pain that is felt down to the lower leg below the knee. 2 Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance. Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening
Exclusion criteria
Exclusion criteria: 1 History of hypersensitivity to Tapentadol. 2 Active or suspected gastrointestinal ulcers, bleeding, or motility disorders within the past 6 months prior to screening. 3 Recent intranasal medication within the 72 hours preceding randomization. 4 Analgesic administration post-operatively before enrolment. 5 Concurrent use of tricyclic antidepressants, selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans, steroids, monoamine oxidase inhibitors, or drugs with potential to lower seizure threshold in the 4 weeks prior to enrolment. 6 History of seizures. 7 Mild to moderate traumatic brain injury, stroke, or brain neoplasm within the past year or severe traumatic brain injury within the last 15 days. 8 Clinically significant ECG abnormalities or QTC greater than or equal to 450 msec for males and greater than or equal to 470 msec for females at screening. 9 Pregnancy or lactation. Bronchial Asthma and COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain severity based on numeric pain rating scale valueTimepoint: Day 1 and Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Need for rescue medicine (i.v. Paracetamol) 2 Change in the Global Sleep Quality Score 3 Safety assessment in terms of adverse events like (Nausea, vomiting, dizziness and allergic reactions post medication)Timepoint: Day 1 and Day 3 | — |
Countries
India
Contacts
Public ContactDr Shobhan Mandal
D Y Patil Medical College and Hospital
Outcome results
None listed