Affects of Tapentadol nasal spray in back ache
- Conditions
- Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- CTRI/2024/05/067264
- Lead Sponsor
- Dr Shobhan Mandal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in pain severity based on numeric pain rating scale valueTimepoint: Day 1 and Day 3
- Secondary Outcome Measures
Name Time Method 1 Need for rescue medicine (i.v. Paracetamol) <br/ ><br>2 Change in the Global Sleep Quality Score <br/ ><br>3 Safety assessment in terms of adverse events like (Nausea, vomiting, dizziness and allergic reactions post medication)Timepoint: Day 1 and Day 3